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Showing 20 of 25369 trials
LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
NCT06513117
Not yet recruiting
Conditions Asthma, Multi Morbidity
Phase NA
Enrollment 30
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

Multimorbidity is a significant issue for many patients with difficult asthma. With patients, we have co-designed a multimodal intervention comprising prescribed exercise, dietary support, breathing pattern retraining and behaviour change to target multimorbidity in difficult asthma

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Behaviour change — healthy conversations to support behaviour change
  • Behavioral: Dietary support — Guidance on healthy eating
  • Behavioral: Breathing pattern retraining — guidance on breathing pattern in exercise
  • Behavioral: Exercise training — Exercise intervention prescribed to participant fitness level

Primary Outcomes

  • Improvement in Asthma Control Questionnaire score (pre and post intervention, at 12 month follow up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2024-10
Completion: 2028-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Southampton
Collaborators: University Hospital Southampton NHS Foundation Trust
Principal Investigators:
  • Anna Freeman, MBBS PhD (PRINCIPAL_INVESTIGATOR) - University of Southampton
Contact Information
Study Contact:
Anna Freeman, PhD MBBS
0238120 5232
a.freeman@soton.ac.uk
Ramesh Kurukulaaratchy, MBBS MD
0238120 5232
R.J.Kurukulaaratchy@soton.ac.uk
Interventions
  • Behavioral: Behaviour change — healthy conversations to support behaviour change
  • Behavioral: Dietary support — Guidance on healthy eating
  • Behavioral: Breathing pattern retraining — guidance on breathing pattern in exercise
  • Behavioral: Exercise training — Exercise intervention prescribed to participant fitness level
Eligibility Criteria
Inclusion Criteria: Aged 18 to 80 years Able and willing to give informed consent Diagnosis of asthma determined by 1. clinical diagnosis of difficult asthma as defined by BTS steps 4-5 and 2. enrolled in WATCH or meet WATCH inclusion criteria. 3. Demonstration of suboptimal symptom control through an ACQ ≥ 1.5 at enrolment 4. Normal lung function or mild/moderate airflow obstruction at baseline (FEV1\>50% predicted) 5. Not achieving WHO recommendations for physical activity for people living with chronic health conditions(62) (150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week) 6)12 lead ECG without clinically significant abnormality - Exclusion Criteria: 1. Intercurrent exacerbation or exacerbation within 4 weeks prior to enrolment in study requiring treatment with oral corticosteroids and/or antibiotics. Note participants can be rescreened 4 weeks post exacerbation if they had not commenced the study 2. Initiation of biologic treatment within 6 months prior to recruitment or during study participation 3. Investigator determined significant change in regular asthma medication in the 12 weeks preceding or during trial period 4. Other medical or psychiatric conditions (including cognitive decline) limiting ability to exercise or that may in the opinion of the study clinician carry inherent risk for exercise 5. Contraindication to ISWT 6. Positive pregnancy test 7. Beta blocker treatment (due to impact on exercise prescription using HR) -
Remission in Adults With Mild-to-moderate Asthma in Thailand
NCT07351916
Recruiting
Conditions Asthma, Mild-to-moderate Asthma, Asthma ...
Phase Not Applicable
Enrollment 289
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this observational study is to determine the prevalence of remission among adults with mild-to-moderate asthma, as well as the factors associated with remission in Thailand. The main question the study aims to answer is: What is the prevalence of remission among adults with severe asthma in Thailand? Participants will complete a questionnaire on asthma symptoms and undergo pulmonary function testing and a blood test once.

Design

Study type: Observational Observational model: Cohort Time perspective: Cross Sectional

Interventions / Regimen

  • Other: Global Initiative for Asthma (GINA) and Asthma Control Test (ACT) questionnaires — GINA and ACT are questionnaires used to assess the level of asthma control.
  • Other: Spirometry — Spirometry is a tool used to assess pulmonary function.
  • Other: Fractional exhaled nitric oxide (FeNO) test — FeNO is a tool used to assess eosinophilic airway inflammation and asthma remission.
  • Other: Blood eosinophil count (BEC) — BEC is a tool used to assess eosinophilic inflammation and asthma remission.

Primary Outcomes

  • Prevalence rate of mild-to-moderate asthma remission (An average of 1 year)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2026-02-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 289 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Thammasat University
Principal Investigators:
  • Narongkorn Saiphoklang, MD (PRINCIPAL_INVESTIGATOR) - Thammasat University Faculty of Medicine
Contact Information
Study Contact:
Narongkorn Saiphoklang, MD
+6629269794
M_narongkorn@hotmail.com
Sirashat Hanvivattanakul, MD
+6629269701
boss32_@hotmail.com
Interventions
  • Other: Global Initiative for Asthma (GINA) and Asthma Control Test (ACT) questionnaires — GINA and ACT are questionnaires used to assess the level of asthma control.
  • Other: Spirometry — Spirometry is a tool used to assess pulmonary function.
  • Other: Fractional exhaled nitric oxide (FeNO) test — FeNO is a tool used to assess eosinophilic airway inflammation and asthma remission.
  • Other: Blood eosinophil count (BEC) — BEC is a tool used to assess eosinophilic inflammation and asthma remission.
Study Locations (2 sites)
Narongkorn Saiphoklang, Pathum Thani, Changwat Pathum Thani 12120 Thailand
Faculty of Medicine, Thammasat University, Pathum Thani, 12120 Thailand
Eligibility Criteria
Inclusion Criteria: * mild-to-moderate asthma * age 18 years or older Exclusion Criteria: * inability to perform spirometry or fractional exhaled nitric oxide (FeNO) test
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
NCT07060079
Recruiting
Conditions Bronchial Asthma, Bronchiectasis, ILD, C...
Phase Not Applicable
Enrollment 120
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

Research is being conducted into chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, and bronchiectasis. The investigation specifically focuses on sleep-disordered breathing (SDB) in individuals with chronic respiratory disease. SDB encompasses a range of conditions, the most common of which is obstructive sleep apnoea. In obstructive sleep apnoea, periodic pauses in breathing (apnoea) lead to reduced blood oxygen levels. To detect these events, patients typically undergo sleep studies that involve monitoring oxygen saturation, heart rate, and respiratory patterns during sleep. When chronic respiratory disease and SDB coexist, breathing disturbances during sleep may be exacerbated. To identify SDB, sleep studies are commonly used to assess oxygen levels, heart rate, and breathing patterns. The objective of this research is to identify differences between patients with chronic respiratory diseases who have SDB and those who do not. This will be achieved by analysing sleep study data using a novel analytical approach. The aim is to determine whether this method can yield more detailed insights into the underlying pathophysiology of these conditions.

Design

Study type: Observational Observational model: Other Time perspective: Prospective

Primary Outcomes

  • Changes in respiratory signals entropy, oxygen saturation , and heart rate recorded using cardiorespiratory polygraphy during a 1-hour daytime and overnight sleep in healthy subjects and patients with chronic respiratory diseases with /without SDB. (2 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-04-30
Completion: 2026-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University College, London
Collaborators: Royal Free Hospital NHS Foundation Trust
Contact Information
Study Contact:
Nawal Alotaibi
02080168375
n.alotaibi@ucl.ac.uk
Interventions
N/A
Study Locations (1 sites)
Royal Free hospital, London, NW3 2QG United Kingdom
Eligibility Criteria
Inclusion Criteria: * All adult patients (≥ 18years) with chronic respiratory disease with/without SDB. * patients who have had previously negative studies as a control group. * Subject is able to read, understand, and sign the informed consent form. * Willing to sleep with portable monitoring devices. Exclusion Criteria: * Patients who are under 18 years of age at the time of the index study. * Contraindications to the use of portable monitoring. * Inability to give informed consent to take part in the study.
Community Exercise Treating Effect on Cardiopulmonary Disease Patients
NCT07154355
Recruiting
Conditions Coronary Heart Disease (CHD), Heart Fail...
Phase NA
Enrollment 200
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn if community-based exercise training can benefit patients aged 18 to 85 with diminished cardiovascular and pulmonary function. The main aim of this study is: • Establish a community or home-based fitness training program for patients with cardiopulmonary insufficiency to improve adherence, safety, and efficacy while alleviating the burden on both patients and society. Researchers will compare community-based exercise training to non-exercise training to see if community-based exercise training works to improve cardiovascular and pulmonary function. Participants will: * Engage in community or home exercise training for 40-60 minutes, five times weekly, during a duration of eight weeks. Exercise modalities are primarily determined by the patients' individual preferences and habits, such as brisk walking, running, swimming, cycling, and hiking. * Adjust the exercise intensity according to their cardiopulmonary exercise test and the person's perceived exertion level. * Utilize fitness bracelets or watches to document statistics during workouts and submit them to the experimenter weekly, covering the five days of exercise within that week. * refrain from making any dietary modifications throughout the trial.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Behavioral: community-based exercise training — The patients will engage in 40-60 minutes of exercise training, either at home or in the community, five times a week, for eight weeks. Brisk walking, jogging, swimming, cycling, and trekking were among the exercise modalities that were chosen mostly based on the patient's individual preferences and habits. To guarantee safe and efficient exercise, exercise intensity was modified based on each person's subjective effort level and the results of their individual cardiorespiratory exercise tests.

Primary Outcomes

  • exercise capacity (at enrollment and week 8)
  • exercise capacity (at enrollment and week 8)
  • life quality (at enrollment and week 8)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-01-30
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guangdong Provincial People's Hospital
Contact Information
Study Contact:
Bin Zeng
13538716788
zengbin@gdph.org.cn
Interventions
  • Behavioral: community-based exercise training — The patients will engage in 40-60 minutes of exercise training, either at home or in the community, five times a week, for eight weeks. Brisk walking, jogging, swimming, cycling, and trekking were among the exercise modalities that were chosen mostly based on the patient's individual preferences and habits. To guarantee safe and efficient exercise, exercise intensity was modified based on each person's subjective effort level and the results of their individual cardiorespiratory exercise tests.
Study Locations (1 sites)
Department of Rehabilitation Medicine Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangzhou, Guangdong 510080 China
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 85 with abnormal pulmonary or cardiovascular function. 2. Individuals who have completed a medical screening form to confirm they are free from illnesses and prescription medications that could impair their ability to complete the required testing and fitness training. 3. Participants who did not engage in structured, systematic moderate-to-intense strength or endurance training during the study period (specifically, not within the previous year). 4. At the onset of the trial, participants were physically active but had never participated in formal exercise more than twice a week. Exclusion Criteria: 1. Patients with neuromuscular or skeletal disorders, or systemic diseases such as diabetes, cancer, or heart disease. 2. Individuals using medications known to affect health or the interpretation of study results. 3. Participants who have engaged in organized, systematic endurance or strength training of moderate to high intensity within the past year. 4. Patients who decline to participate in the study. 5. Other medical conditions or states that render exercise training inappropriate.
A Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma
NCT07532265
Recruiting
Conditions Severe Asthma
Phase PHASE2
Enrollment 512
Locations 14 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) Over a 12-Week Treatment Period in Patients With Severe Asthma Not Controlled With Medium to High Dose ICS/LABA

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: Frevecitinib — Frevecitinib (KN-002) delivered via a dry powder inhaler (DPI)
  • Drug: Placebo — Matching placebo to frevecitinib

Primary Outcomes

  • Pre-BD FEV1 (Week 12)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-07-16
Completion: 2027-11-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 512 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kinaset Therapeutics Inc
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Frevecitinib — Frevecitinib (KN-002) delivered via a dry powder inhaler (DPI)
  • Drug: Placebo — Matching placebo to frevecitinib
Study Locations (14 sites)
Research site, Lancaster, California 93534 United States
Research site, San Jose, California 95117 United States
Research site, Brandon, Florida 33511 United States
Research site, Miami, Florida 33137 United States
Research site, Tampa, Florida 33607 United States
Research site, Chicago, Illinois 60612 United States
Research site, Kansas City, Missouri 66160 United States
Research site, Charlotte, North Carolina 28277 United States
Research site, Pittsburgh, Pennsylvania 15213 United States
Research site, Rock Hill, South Carolina 29732 United States
Eligibility Criteria
Inclusion Criteria: Capable of understanding the written informed consent, provides signed and witnessed written informed consent prior to any study-related procedures, and agrees to comply with protocol requirements. Body mass index between 18 to 40 kg/m2 and weight ≥40 kg at screening. Documented physician-diagnosed asthma for at least 12 months prior to screening. Has received a physician-prescribed asthma controller regimen with medium dose or high dose ICS plus LABA, with or without additional controller medications for at least 6 months prior to screening and the dose of ICS and additional controller(s) must be stable for at least 4 weeks prior to screening and throughout the screening/run-in period. Has a pre-bronchodilator FEV1 value of ≥40% and ≤80%, predicted, at screening and at Day 1. Has a post-bronchodilator reversibility of FEV1 ≥12% and ≥200 mL documented during screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol). Has an ACQ-6 score of ≥1.5 during screening (ie, Visit 1 and Visit 2). Has a documented history of at least 1 asthma exacerbation in the 12 months prior to the screening visit, while using medium to high dose ICS/LABA therapy Acceptable inhaler, peak flow meter, and spirometry techniques during the screening/run-in period. ≥80% compliance with required use of the ePRO device within the last 14 days of the screening/run-in period. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions throughout the study and continue using such precautions for 16 weeks after the final dose of study treatment. Exclusion Criteria: Current smokers or participants with a smoking history of ≥10 pack years Participants with a current history of angina or history of myocardial infarction, stroke, or TIAs within the past 12 months from screening are disallowed. Participants with a history of pulmonary embolic or thrombotic events, or genetic or autoimmune (eg anti-phospholipid syndrome) predisposition for thrombosis are disallowed. Any concomitant respiratory disease that, in the opinion of the investigator and/or medical monitor, will interfere with the evaluation of the investigational product or interpretation of participant safety or study results Any clinically relevant abnormal findings in hematology, clinical chemistry, coagulation, or urinalysis (laboratory results from visit), physical examination, vital signs during the screening/run-in period which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study Evidence of active liver disease including jaundice or AST, ALT, or bilirubin greater than twice the upper limit of normal. History of cancer Participants with a respiratory tract infection that has not fully resolved by screening, or who experience an RTI during screening or at Day 1. Evidence of a clinically significant infection or receiving treatment with systemic antibiotic, anti-parasitic, or antiviral medications at Day 1. Known history of active TB or a positive QFT-G test for TB during screening. A positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. A positive human immunodeficiency virus test at screening or participant taking antiretroviral medications, as determined by medical history and/or participants verbal report. History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation. Use of oral or topical JAK inhibitors for any reason or use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot glucocorticoid, or any experimental anti-inflammatory therapy) within 3 months prior to screening and throughout the study. Receipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior to screening, whichever is longer and throughout the study. Prescription of regular daily oral corticosteroids within 4 weeks prior to screening or during the screening/run-in period and throughout the study. Systemic glucocorticoid burst including taper within 15 days prior to screening or during the screening/run-in period and throughout the study. Prescription of concomitant parenteral monoclonal antibody therapy for the management of asthma or any other condition within a specified period prior to the screening visit Pregnant, breastfeeding, or lactating females. History of chronic alcohol or drug abuse within 12 months prior to screening, as determined by the investigator. Planned surgical procedures requiring general anesthesia or in-patient status for \>1 day during the conduct of the study. Receipt of any live or attenuated vaccines within 15 days prior to screening. Participants who have undergone bronchial thermoplasty. Prolonged QTcF \>470 ms at screening or baseline.
A Cohort Study of Risk Factors and Prognosis for Frequent Acute Asthma Exacerbations Phenotype
NCT06621056
Recruiting
Conditions Asthma Exacerbations
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

Acute asthma exacerbations are an important public health problem and a major cause of disease progression and healthcare burden for people with asthma. Frequent acute exacerbations are likely to be a distinct asthma phenotype. Further research is needed to identify risk factors for frequent acute exacerbations, but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes. Moreover, most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma, whereas a certain proportion of non-severe asthmatics may also experience frequent acute exacerbations, the risk factors of which remain to be further evaluated. The main objectives of this project are to compare the baseline clinical, inflammatory, pathophysiological, comorbidities, environmental pollutants and meteorological exposure characteristics of patients with frequent acute exacerbations and those with non-frequent acute exacerbations irrespective of asthma severity, and to develop a disease prediction model for frequent acute exacerbations; and to develop a cohort of patients with frequent acute exacerbations of asthma, observe their prognosis and response to treatment, and search for prognostic factors associated with them. The successful implementation of this study will help in the early identification of patients with frequent acute exacerbations, clarify the factors associated with poor prognosis in this group of patients, and thus provide an individualized plan for the treatment and prevention of this type of patients, which is of great significance in achieving good asthma control, reducing the burden of disease, decreasing the cost of healthcare, and saving clinical healthcare resources and costs.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: not applicable for observational research — This is an observational research and has no intervention

Primary Outcomes

  • acute asthma exacerbation (baseline and during 1 year follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2022-01-01
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Peking University Third Hospital
Contact Information
Study Contact:
Chun Chang
19800300860
doudou1977bysy@sina.com
Interventions
  • Other: not applicable for observational research — This is an observational research and has no intervention
Study Locations (1 sites)
Peking University third hospital, Beijing, Beijing Municipality 100191 China
Eligibility Criteria
Inclusion Criteria: * Patients with asthma attending the outpatient clinic of the Department of Respiratory and Critical Care Medicine of Peking University Third Hospital met the diagnostic criteria for asthma proposed by the guidelines for the prevention and treatment of bronchial asthma. Exclusion Criteria: * Combination of chronic obstructive pulmonary disease, bronchiectasis, pneumonia, obstructive sleep apnea hypoventilation syndrome, malignancy; combination of various acute and chronic respiratory failure; combination of severe cardiovascular disease; pregnant women.
A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine
NCT07274631
Recruiting
Conditions Chronic Obstructive Pulmonary Disease, A...
Phase Not Applicable
Enrollment 470
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-13
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Chronic inflammatory pulmonary diseases, including asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, cystic fibrosis (CF), primary ciliary dyskinesia (PCD) and interstitial lung diseases (ILD) are characterised by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognostic features are highly variable and heterogeneous. Several phenotypes have been described within the same pathology, as similar phenotypic traits between different pathologies, or the coexistence of components of several diagnoses in the same patient, suggesting shared underlying mechanisms that could represent new therapeutic targets, beyond the initial medical diagnosis. The objectives of this prospective study are to analyze the phenotypic characteristics (clinical, demographic, biological, morphological, pathological, and microbiological characteristics) together with respiratory exposures and underlying mechanisms involving airway epithelium and inflammation processes in a cohort of patients diagnosed with asthma, COPD, bronchiectasis, CF, PCD and ILD.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: Non applicable — Non applicable

Primary Outcomes

  • pheno-endotypes of inflammatory respiratory disease (Baseline)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-09-15
Completion: 2040-09-15
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 470 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: CHU de Reims
Contact Information
Study Contact:
Jeanne-Marie PEROTIN-COLLARD
03 10 73 67 63
jmperotin-collard@chu-reims.fr
Gaëtan DESLEE
03 26 78 76 11
gdeslee@chu-reims.fr
Interventions
  • Other: Non applicable — Non applicable
Study Locations (1 sites)
Chu Reims, Reims, 51092 France
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Follow-up for one of the following conditions: asthma, COPD, bronchiectasis (DDB), cystic fibrosis (CF), primary ciliary dyskinesia (PCD), or interstitial lung diseases (ILD) * Healthy volunteers (controls) Exclusion Criteria: * Subjects protected by law (e.g., legal incapacity) * Any condition preventing informed consent or participation
Intragastric Balloon in Obese Patients With Uncontrolled Asthma
NCT05364957
Recruiting
Conditions Obesity, Asthma
Phase NA
Enrollment 84
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

The aim of this project is to study the effect of an intragastric balloon (IGB) on asthma control in obese patients. Obese patients with uncontrolled asthma will be recruited and randomly assigned to two intervention arms : an intragastric balloon combined with diet and exercise versus diet and exercise alone (control group). The primary endpoint will be the proportion of patients with an improvement based on an Asthma Control Questionnaire (ACQ) score ≥ 0.5 at 1 year compared to baseline.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: Intragastric balloon device — Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
  • Procedure: Dietary — The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).
  • Procedure: Exercise intervention — Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.

Primary Outcomes

  • Asthma Control Survey (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-05-12
Completion: 2029-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Toulouse
Principal Investigators:
  • Guilleminault M Laurent, MD (PRINCIPAL_INVESTIGATOR) - Study principal Investigator Toulouse University Hospital
Contact Information
Study Contact:
Guilleminault Laurent, MD
05 67 77 18 50
guilleminault.l@chu-toulouse.fr
Interventions
  • Device: Intragastric balloon device — Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
  • Procedure: Dietary — The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).
  • Procedure: Exercise intervention — Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.
Study Locations (1 sites)
University Hospital Toulouse, Toulouse, Occitanie 31000 France
Eligibility Criteria
Inclusion Criteria: 1. Men and women aged between 18 and 65 years 2. Asthma according to the Global Initiative for Asthma (GINA) criteria 3. Patients with uncontrolled asthma based on an ACQ score ≥1.5 despite inhaled corticosteroids ± long acting bronchodilators (LABA) 4. Patients with grade I obesity (BMI\> 30 kg/m² and \< 35 kg/m²) or morbid obesity (BMI\<40 or ≥35 kg/m² with serious physiological risks, as recommended by the French Health Authorities) with contraindications for or refusal of bariatric surgery. 5. Effective contraception for women 6. Patients who have signed a written informed consent form 7. Patients with health insurance 8. Complete COVID-19 vaccination schedule according to current guidelines Exclusion Criteria: 1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) 2. Blood eosinophilia greater than 4.5 G/I 3. Treatment by biotherapy within the 12 months after inclusion 4. Cancer diagnosed within the last 5 years 5. Smoking \> 10 packs/year (PA) 6. One asthma exacerbation in the 4 weeks leading up to the inclusion visit or IGB placement. 7. Treatment with orlistat Xénical® or GLP1 analogues or regular consumption of narcotics (heroin, cocaine and amphetamines). Analgesic treatments, including level 3, are authorized during the study. 8. Any patient for whom IGB is contraindicated \[criteria defined by the French Society for Digestive Endoscopy) and the French Think-Tank for Hepato-Gastroenterology Practices\]: 8.1 Severe cognitive or psychiatric disorders, chronic alcoholism, drug addiction 8.2 Severe and unstabilised eating disorders: bulimia or history of anorexia 8.3 History of gastric surgery including the ring insertion 8.4 Haemostasis disorders 8.5 Anticoagulant or non-steroidal anti-inflammatory medicines 8.6 Severe liver disease 8.7 Pregnancy or desire to become pregnant or breastfeeding 8.8 Anticipated failure to comply with prolonged medical follow-up 8.9 Large hiatal hernias \> 5 cm, inflammatory (Crohn's) or stenosing small bowel disease, pyloric stenosis and structural abnormalities of the digestive tract 8.10 Systemic lupus erythematous 8.11 Severe oesophagitis and active gastroduodenal ulcer 8.12 Silicone allergy 9. Patient under guardianship or tutorship, persons placed under the protection of justice or persons participating in another search including an exclusion period still in progress
Humidity Asthma Interventions for Low Socioeconomic Status Children
NCT07453667
Recruiting
Conditions Pediatric Asthma
Phase NA
Enrollment 80
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-13
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this intervention study is to assess the effectiveness of low-cost humidity and mold reduction interventions in the home for reducing pediatric asthma. The study will have two groups, a treatment group that receives the healthy home interventions during the study and a second control group that will receive these after the study. We will compare pediatric asthma before and three months after the healthy home interventions are performed.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Other: Healthy home intervention — Healthy home interventions including low cost humidity interventions.

Primary Outcomes

  • Change in pediatric asthma control (Baseline and 3 months)
  • Change in asthma-related quality of life (Baseline and 3 months)
  • Hospitalizations (Baseline and 3 months)
  • Missing work/school (Baseline and 3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-05-02
Completion: 2027-05
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Case Western Reserve University
Collaborators: The Cleveland Clinic
Principal Investigators:
  • Bridget Hegarty, PhD (PRINCIPAL_INVESTIGATOR) - Case Western Reserve University
Contact Information
Study Contact:
Bridget Hegarty, PhD
216-368-2950
beh53@case.edu
Interventions
  • Other: Healthy home intervention — Healthy home interventions including low cost humidity interventions.
Study Locations (2 sites)
Case Western Reserve University, Cleveland, Ohio 44106 United States
Cleveland Clinic, Cleveland, Ohio 44195 United States
Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of asthma by one child (\< 18 years of age) living within the home * Parent/guardian able to complete informed consent * Residence within the City of Cleveland or immediate suburbs (e.g., East Cleveland, Garfield Heights, Warrensville Heights, Parma, Brook Park, Brooklyn/Old Brooklyn) Exclusion Criteria: * \> 18 years of age * Rental property with landlord unwilling or unable to give consent for remediation
Controls for Respiratory Diseases
NCT03120481
Recruiting
Conditions Chronic Obstructive Pulmonary Disease, A...
Phase Not Applicable
Enrollment 1572
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

This is the registry of control participants for patients with various respiratory diseases. We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam Center for routine health check-up, and enrolled patients who agree to participate in the study. The participants undergo baseline questionnaires, provide blood specimen and information of the results of health check-up. We will include participants as controls if they have no significant respiratory symptom and no significant radiographic abnormality. The data from this registry will be compared with those from other registry of various respiratory diseases

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: no intervation — no intervention

Primary Outcomes

  • Mortality (20 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2017-04-10
Completion: 2037-02-28
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: true
Enrollment: 1572 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Seoul National University Hospital
Principal Investigators:
  • Chang-Hoon Lee, M.D. (PRINCIPAL_INVESTIGATOR) - Seoul National University Hospital
Contact Information
Study Contact:
Chang-Hoon Lee, M.D.
82-2-2072-4743
kauri670@gmail.com
Interventions
  • Other: no intervation — no intervention
Study Locations (1 sites)
Seoul National University Healthcare System Gangnam Center, Seoul, Seoul 06236 South Korea
Eligibility Criteria
Inclusion Criteria: * 19-90 years old male and female * underwent health check-up including chest radiography * obtained informed consent Exclusion Criteria: * those who showed a significant abnormal finding of chest radiography * those who reported a significant respiratory symptoms
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
NCT06273072
Recruiting
Conditions Asthma, Asthma Chronic, Overweight and O...
Phase PHASE2
Enrollment 100
Locations 2 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: Metformin hydrochloride extended-release tablets — titrated to 2000 mg once daily
  • Drug: Visually identical placebo Metformin hydrochloride extended-release tablets — placebo

Primary Outcomes

  • Number of completed telemedicine visits (Baseline to week 24)
  • Adherence to study drug (Baseline to week 24)
  • Retention rate (Baseline to week 24)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-12-09
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Johns Hopkins University
Collaborators: Baylor College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Temple University
Principal Investigators:
  • Meredith C McCormack, M.D., M.H.S. (PRINCIPAL_INVESTIGATOR) - Johns Hopkins University
  • Tianshi D Wu, M.D., M.H.S. (PRINCIPAL_INVESTIGATOR) - Baylor College of Medicine
Contact Information
Study Contact:
Rachelle Koehl, M.S.
410-955-1530
rkoehl1@jhmi.edu
Meredith C McCormack, M.D., M.H.S.
410-550-6205
mmccor16@jhmi.edu
Interventions
  • Drug: Metformin hydrochloride extended-release tablets — titrated to 2000 mg once daily
  • Drug: Visually identical placebo Metformin hydrochloride extended-release tablets — placebo
Study Locations (2 sites)
Johns Hopkins University, Baltimore, Maryland 21224 United States
Baylor College of Medicine, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Physician-diagnosed asthma on maintenance therapy * Not well-controlled asthma (ACT score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months) * Overweight or obesity: Body mass index ≥25kg/m2 * Adult: Age ≥18 Exclusion Criteria: * Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding * Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months * Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis * Active smoking or former smoker with ≥20 pack-year smoking history * Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2 * Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man * Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal or prior diagnosis of liver disease * Anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females * Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss * Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes) * Participation in any other clinical trial (observational studies are permitted)
Effects of a Pulmonary and Cardiovascular Rehabilitation Program
NCT06772922
Recruiting
Conditions Respiratory Muscle Weakness, Quality of ...
Phase NA
Enrollment 26
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Other: Exercise — effect of exercise after three months (comparison of the patient with himself)

Primary Outcomes

  • Functional Capacity (three months)
  • Inspiratory muscle strength (three months)
  • Expiratory muscle strength (three months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2019-03-03
Completion: 2025-12-20
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 26 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Campinas, Brazil
Contact Information
Study Contact:
Letícia Baltieri
+55(19)35218936
lbaltieri@yahoo.com.br
Interventions
  • Other: Exercise — effect of exercise after three months (comparison of the patient with himself)
Study Locations (1 sites)
Unicamp, Campinas, São Paulo Brazil
Eligibility Criteria
Inclusion Criteria: * Candidates for the pulmonary rehabilitation program: users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. * Candidates for the cardiovascular rehabilitation program: users diagnosed with acute myocardial infarction, myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. * Referral with medical clearance for rehabilitation Exclusion Criteria: * Patients with any contraindication to aerobic or muscle-strengthening physical exercise, such as significant arrhythmias, untreated heart disease, myocarditis, recent or untreated pulmonary embolism, and uncontrolled systemic arterial hypertension, among other conditions.
Evaluation of 3D Magnetic Resonance Spirometry: Comparison with Spirometry in Healthy Subjects and Patients with Respiratory Pathologies (asthma, COPD, Bilateral Lung Transplant)
NCT05724745
Recruiting
Conditions Asthma, COPD, BOS
Phase NA
Enrollment 240
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-13
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Spirometry is now the gold standard technique for assessing lung function in humans. From the shape of a flow-volume curve measured while the patient, trained by the practitioner, performs forced breaths, the forced vital capacity (FVC) and the forced expiratory volume in one second (FEV1) can be deduced and the pulmonologist is able to detect and characterize respiratory diseases as well as to evaluate current treatments. This technique is non-invasive and simple. It is widely available, robust, reproducible and sensitive to intervention. However, it requires proactive cooperation from the patient and only measures global pulmonary ventilation, without locoregional information. An innovative strategy and an original study framework have been developed in the BioMaps laboratory to establish local maps of flow-volume curves across the lung and to jointly analyze ventilatory function and mechanical behavior at any point in the lung: 3D magnetic resonance spirometry. As respiratory mechanics fundamentally supports ventilatory function, this technique should open a new avenue to non-invasively explore lung function while providing a better diagnosis of regional lung diseases.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Diagnostic Test: 1. Standard spirometry — Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
  • Diagnostic Test: 2. 3D dynamic lung MRI at UTE in prone and supine positions — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.
  • Drug: 3. Reversibility test with salbutamol — Reversibility test with salbutamol administered using a pressurized metered dose bottle and an inhalation chamber at a dosage of 100 μg, 4 times (i.e., 400 μg in total).
  • Diagnostic Test: 4. 3D dynamic lung MRI at UTE in supine and prone position — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.

Primary Outcomes

  • Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC (2 months)
  • Difference of expiratory volume in 1 s (SEV1) and tidal volume (TV) between the left and right lungs (2 months)
  • Difference in expiratory volume in 1 s (SEV1) and tidal volume (TV) for the anterior-posterior, inferior-superior and medial-lateral lung regions (2 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-05-26
Completion: 2028-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 240 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Commissariat A L'energie Atomique
Contact Information
Study Contact:
MARTINS Bernadette
+33169087460
bernadette.martins@cea.fr
Interventions
  • Diagnostic Test: 1. Standard spirometry — Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
  • Diagnostic Test: 2. 3D dynamic lung MRI at UTE in prone and supine positions — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.
  • Drug: 3. Reversibility test with salbutamol — Reversibility test with salbutamol administered using a pressurized metered dose bottle and an inhalation chamber at a dosage of 100 μg, 4 times (i.e., 400 μg in total).
  • Diagnostic Test: 4. 3D dynamic lung MRI at UTE in supine and prone position — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.
Study Locations (1 sites)
CEA | Service Hospitalier Fréderic Joliot, Orsay, France 91401 France
Eligibility Criteria
Inclusion Criteria: Generic inclusion criteria * Ability to understand the nature and objectives of the study * Ability to remain immobile in an MRI scanner in supine position for the entire duration of the acquisitions * Ability to give free and informed written consent Specific inclusion criteria for healthy volunteers * Age: 18-45 years * No known and diagnosed pulmonary pathology such as respiratory insufficiency, COPD, asthma or cancer * Ability to remain motionless in an MRI scanner in a prone position for a total of 50 min. * Non-smoker and non-smoker Specific inclusion criteria for asthma patients * Age: 18-80 years * Asthma of varying degrees of severity, depending on inhalation required to achieve control: * Diagnosis of asthma classified as moderate according to the Global initiative for asthma (GINA) guidelines for at least 6 months * Diagnosis of asthma classified as severe according to the Global initiative for asthma (GINA) guidelines for at least 6 months months with initiation of biotherapy planned by their pulmonologist * Non-smoker and non-vapourist Specific inclusion criteria for COPD patients * Age: 40-80 years * COPD of varying degrees of severity: * Diagnosis of COPD classified as moderate according to the Global initiative for chronic obstructive lung disease guidelines (GOLD 2: VEMS = 50-79%) * Diagnosis of COPD classified as severe according to the guidelines for chronic obstructive lung disease (GOLD 3: VEMS = 30-49%) Specific inclusion criteria for patients with bilateral lung transplants with BOS * Age: 18-90 years * Irreversible FEV1 \< 80% of baseline with FEV1/FVC ratio FEV1/FVC \< 0.7 * Absence of visible parenchymal opacity on CT scan (non inclusion of mixed RAS/CLAD) * Absence of significant bronchial stenosis (having required endoscopic endoscopic treatment) * No diaphragmatic involvement (established by sniff test under fluoroscopy fluoroscopy or diaphragmatic ultrasound) Specific inclusion criteria for patients with bilateral lung transplants without BOS * Age: 18-90 years * FEV1 \> 90% baseline for more than 24 months after the date of date of lung transplantation * Absence of significant bronchial stenosis (requiring endoscopic endoscopic treatment) * Absence of diaphragmatic impairment (established by sniff test under fluoroscopy or diaphragmatic ultrasound)
Multimodal Tongue-Pulse Information Fusion for Syndrome Diagnosis and Cohort Study in Children With Asthma
NCT07383883
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 1000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-13
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Asthma is one of the most prevalent chronic respiratory diseases in children, and accurate phenotyping and disease monitoring remain challenging in routine clinical practice. This observational cohort study aims to investigate the clinical value of multimodal tongue and pulse information in the syndrome diagnosis and phenotypic characterization of pediatric asthma. Children aged 5-18 years with a confirmed diagnosis of asthma will be enrolled at Shanghai Children's Medical Center and followed in routine outpatient care. Standardized tongue images and pulse wave data will be collected using validated acquisition devices during visits when lung function testing is performed. Quantitative features extracted from tongue and pulse data will be integrated with clinical information, including asthma stage, lung function parameters, eosinophil counts, allergic sensitization status, and Asthma Control Questionnaire-5 (ACQ-5) scores. The primary objective is to evaluate the associations between tongue-pulse multimodal features and asthma clinical stages and pulmonary function. Secondary objectives include exploring their relationships with airway inflammation and asthma control status. This study seeks to establish a non-invasive, objective, and quantifiable approach to asthma phenotyping, providing evidence for integrating traditional diagnostic features with modern clinical data to support precision management of pediatric asthma.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: No intervention (observational study) — No intervention (observational study)

Primary Outcomes

  • Association Between Tongue-Pulse Multimodal Features and Pulmonary Function in Pediatric Asthma (During routine outpatient visits at baseline and follow-up when pulmonary function testing is performed (up to 12 months))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2026-02-01
Completion: 2028-01-31
Eligibility
Age: 5 Years
Sex: ALL
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Children's Medical Center
Principal Investigators:
  • Yong Yin (PRINCIPAL_INVESTIGATOR) - Shanghai Children's Medical Center
Contact Information
Study Contact:
Yong Yin
86-021-38626161
yinyong9999@163.com
Interventions
  • Other: No intervention (observational study) — No intervention (observational study)
Study Locations (1 sites)
Shanghai Children's Medical Center, Shanghai, 200127 China
Eligibility Criteria
Inclusion Criteria: * Children aged 5 to 18 years. * Clinically diagnosed asthma according to established pediatric asthma guidelines. * Receiving routine outpatient follow-up at Shanghai Children's Medical Center. * Able to cooperate with tongue image acquisition and pulse wave data collection. * Able to perform pulmonary function testing when clinically indicated. * Written informed consent obtained from parents or legal guardians, with assent from the child when appropriate. Exclusion Criteria: * Presence of other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis, primary ciliary dyskinesia). * Congenital cardiopulmonary malformations or significant cardiovascular disease. * Acute respiratory infection or fever at the time of data collection. * Severe systemic diseases or immunodeficiency that may affect study participation. * Inability to comply with study procedures or incomplete clinical data.
A Study of CDX-622 in Participants With Mild to Moderate Asthma
NCT07330778
Recruiting
Conditions Mild to Moderate Asthma
Phase PHASE1
Enrollment 12
Locations 4 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: CDX-622 — Administered Intravenously

Primary Outcomes

  • To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma. (Day 1 up to Day 85 (12 weeks))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-06-01
Completion: 2027-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 12 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Celldex Therapeutics
Contact Information
Study Contact:
Celldex Therapeutics
844-723-9363
clinicaltrials@celldex.com
Interventions
  • Drug: CDX-622 — Administered Intravenously
Study Locations (4 sites)
University of California, San Francisco, San Francisco, California 94143 United States
The University of Kansas Medical Center, Kansas City, Kansas 66160 United States
Brigham and Women's Hospital, Boston, Massachusetts 02115 United States
University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC, Pittsburgh, Pennsylvania 15213 United States
Eligibility Criteria
Key Inclusion Criteria: 1. Males and females, ≥ 18 years of age 2. Diagnosis of mild to moderate asthma for at least 12 months 3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal 4. Airway reversibility ≥ 12% and 200 mL improvement in FEV1 5. Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment 6. Willing and able to comply with all study requirements and procedures Key Exclusion Criteria: 1. Females who are pregnant or nursing 2. Pulmonary disease other than asthma 3. Systemic diseases with elevated eosinophils other than asthma 4. Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months 5. History of needing ventilator support due to asthma 6. Current nasal polyps 7. Severe or uncontrolled asthma 8. History of smoking or vaping within the past 6 months 9. Tuberculosis, hepatitis B or C virus, or HIV 10. Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics. 11. Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab Additional protocol defined inclusion and exclusion criteria could apply.
Association Analysis of Depression and Asthma
NCT07377552
Not yet recruiting
Conditions Depression,Asthma
Phase Not Applicable
Enrollment 500
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-13
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Main Studies Integrate retrospective studies, observational studies, and Mendelian randomization (MR) study methods to systematically analyze the strength and direction of the association between depression and asthma. Explore whether a causal relationship exists between depression and asthma, and identify potential confounding factors and effect modifiers. Secondary Studies Screen for key confounding variables that affect the association between depression and asthma (e.g., age, gender, lifestyle, comorbidities, etc.). Analyze the correlation between depression and the severity of asthma. Verify the stability of instrumental variables (IVs) and the reliability of causal effects in the MR study. Key Term Supplementary Explanations Effect modifiers: Factors that alter the strength or direction of the association between an exposure (e.g., depression) and an outcome (e.g., asthma) (e.g., certain genes or medications may modify how depression influences asthma risk). Instrumental variables (IVs): Genetic variants used in MR studies that are associated with the exposure (e.g., depression-related SNPs) but not directly associated with the outcome (e.g., asthma) except through the exposure, helping to reduce confounding and infer causality.

Design

Study type: Observational Observational model: Other Time perspective: Cross Sectional

Primary Outcomes

  • Integrate retrospective studies, observational studies, and Mendelian randomization (MR) methods to systematically analyze the strength of the association between depression and asthma. (November 1, 2025 - October 31, 2026)
  • Explore whether a causal relationship exists between depression and asthma, and identify potential confounding factors. (November 1, 2025 - October 31, 2026)
  • Screen for key confounding variables that influence the association between depression and asthma. (November 1, 2025 - October 31, 2026)
  • Analyze the correlation between depression and the severity of asthma. (November 1, 2025 - October 31, 2026)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-01-31
Completion: 2026-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact Information
Study Contact:
Zhenghua Wu
+86-15901617923
wuzhenghua@sjtu.edu.cn
Interventions
N/A
Eligibility Criteria
Inclusion Criteria For Retrospective Study * Age ≥ 18 years old * Complete medical records, including demographic characteristics (age, gender, ethnicity, etc.), clinical diagnosis information (diagnosis time of depression/asthma, diagnostic basis), treatment plans (medication type, dosage), and follow-up records * Depression diagnosis conforms to relevant clinical criteria; asthma diagnosis conforms to Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition) For MR Study (GWAS Data) * Data have undergone strict quality control * Study participants are of European ancestry (to reduce population stratification bias) * Clear division of case group and control group, as well as available sample size information Exclusion Criteria For Retrospective Study * Comorbidity with other severe mental illnesses (e.g., schizophrenia, bipolar affective disorder) * Comorbidity with severe respiratory diseases (e.g., chronic obstructive pulmonary disease \[COPD\], pulmonary fibrosis, lung cancer) * Comorbidity with severe organ failure (e.g., heart, liver, or kidney failure) * Lack of key information in medical records (e.g., diagnosis time, core symptoms, treatment plan) For MR Study (IVs Screening) * Single nucleotide polymorphisms (SNPs) with an association significance P-value ≥ 5×10-⁸ with the exposure (depression/asthma) * SNPs with high linkage disequilibrium (LD, r² ≥ 0.001, distance ≤ 10000 kb) * SNPs located in coding regions or those that may affect gene expression regulation (at risk of horizontal pleiotropy) * SNPs with an F-statistic \< 10 (at risk of weak instrumental variable bias)
A Population-based Investigation of Asthma in the Telemark Region of Norway
NCT02073708
Active, positions filled
Conditions Obstructive Lung Diseases, Respiratory S...
Phase Not Applicable
Enrollment 2000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-13
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Respiratory conditions impose an enormous burden on the individual and the society. According to the WHO World Health Report 2000, the top five respiratory diseases - including asthma and COPD - account for 17% of all deaths and 13% of all Disability-Adjusted Life Years (DALYs). Obstructive lung diseases are among the most common chronic diseases in working-aged populations affecting \~40 million individuals in Europe. The greatest economic burden of respiratory diseases on health services and lost production in the EU is due to COPD and asthma, at about €20 billion each for healthcare and €25 billion and €15 billion, respectively, for lost production. For Norway, there are no estimates of asthma prevalence for the country as a whole, but 80/1000 women and 55/1000 men used asthma medication in 2013 according to the national prescription register. Estimated annual deaths in Norway due to COPD were 4070 in 2015, which is 30% higher than for lung cancer. Unfortunately, a substantial proportion of patients are still difficult to treat. This underlines the need for better primary prevention and more knowledge regarding causes and exacerbating factors. Several risk factors for chronic respiratory diseases are identified, most important tobacco smoke, closely followed by air pollution and occupational exposure. However, according to recent reviews there is a lack of understanding regarding environmental risk factors and mechanisms of how these affect respiratory health, the importance of biological markers and comorbidity, and of socioeconomic risk factors. Moreover, there is a need for assessment of interactions between risk factors and between the individual and the environment. Telemark has a high proportion of craft- and industrial workers providing exposure contrasts. Furthermore, the use of medication against respiratory diseases and the rate of sick leave are higher in Telemark than elsewhere in Norway. Moreover, the county has a high rate of disability. There are previous studies from other parts of Norway, which have estimated the occurrence of respiratory diseases and provided valuable knowledge regarding some risk factors. However, these studies use crude measures of self-reported exposure and do not provide sufficient information on how to target intervention and implement effective prevention. In contrast to the Telemark study, these studies have not included register data or advanced modelling of environmental exposure.

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Primary Outcomes

  • The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity (Five years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2018-02-01
Completion: 2035-12-31
Eligibility
Age: 16 Years
Sex: ALL
Volunteers: false
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sykehuset Telemark
Collaborators: Oslo University Hospital, National Institute for Occupational Safety and Health (NIOSH/CDC), Göteborg University
Principal Investigators:
  • Johny Kongerud, Professor (STUDY_DIRECTOR) - Oslo University, Oslo University Hospital
  • Anne Kristin Møller Fell, PhD (PRINCIPAL_INVESTIGATOR) - Sykehuset Telemark
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Telemark Hospital, dep. of Occupational and Environmental Medicine, Skien, Telemark 3710 Norway
Eligibility Criteria
Inclusion Criteria: * Physician diagnosed asthma * Controls without physician-diagnosed asthma Exclusion Criteria: * inability to fill-inn the questionnaire
Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
NCT06472310
Recruiting
Conditions Severe Asthma
Phase Not Applicable
Enrollment 5000
Locations 40 sites
Compensation Compensation varies
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

This study is an observational multicenter cross-sectional study. Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care (except biologics). Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way). This non-interventional study does not imply any intervention into a routine clinical practice, and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.

Design

Study type: Observational Observational model: Other Time perspective: Other

Primary Outcomes

  • To characterise the profile of routine therapy used for patients with uncontrolled SA not receiving biological therapy in proportion of patients receiving different classes of drugs will be calculated (June 2024 - June 2027)
  • To determine the pattern and trends of OCS prescription (June 2024 - June 2027)
  • To describe clinical and demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the inclusion into the study will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the primary asthma diagnosis will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the diagnosis of SA will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation data on mean body mass index (BMI) will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with overweight will be calculated (June 2024 - June 2027)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-06-06
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 5000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
N/A
Study Locations (40 sites)
Research Site, Astrakhan, Russia
Research Site, Barnaul, Russia
Research Site, Blagoveshchensk, Russia
Research Site, Bryansk, Russia
Research Site, Chelyabinsk, Russia
Research Site, Gatchina, Russia
Research Site, Irkutsk, Russia
Research Site, Izhevsk, Russia
Research Site, Kazan', Russia
Research Site, Kemerovo, Russia
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years at the time of inclusion; 2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study; 3. Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score \> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and/or ALP, and/or LAMA, and/or systemic corticosteroids (sCS), and/or immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion. Uncontrolled asthma is defined as ACQ-5\>1.5. 4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records. Exclusion Criteria: 1. Patients receiving any biological therapy currently or within 52 weeks prior to inclusion; 2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis; 3. The participation in any clinical study currently or within 52 weeks prior to inclusion; 4. An acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results.
Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma
NCT07613671
Not yet recruiting
Conditions Asthma (Diagnosis)
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

Asthma is a chronic inflammatory disease of the airways that results in tissue remodeling, airflow limitation, and bronchial hyperresponsiveness. This study aims to evaluate the long-term effects of photobiomodulation using an LED vest in the management of pediatric asthma. It is a randomized clinical trial involving children aged 6 to 17 years diagnosed with mild to moderate asthma, divided into two groups: an intervention group (using a vest with active LEDs) and a control group (using the vest turned off, simulating the intervention without light emission). The methodology includes clinical and functional assessments such as spirometry, the Asthma Control Test (ACT), the GINA questionnaire, and the Incremental Step Test (IST), which measures exercise tolerance. Photobiomodulation through LEDs promotes cellular biostimulation without thermal effects, modulating inflammatory processes and optimizing tissue regeneration. It is expected that the LED vest will contribute to improving pulmonary function, enhancing quality of life, and complementing conventional treatments. This project aims to advance the clinical application of photobiomodulation as an accessible and effective therapeutic alternative for pediatric asthma.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Other: Photobiomodulation — 1\. Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature. Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:\*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator.
  • Other: Exercise — Supervised Physical Training: The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring.

Primary Outcomes

  • Functional exercise capacity (From enrollment to the end of treatment at 8 week)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-07-30
Completion: 2028-01-30
Eligibility
Age: 6 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Nove de Julho
Principal Investigators:
  • Luciana M Sampaio, Dra (PRINCIPAL_INVESTIGATOR) - University of Nove de Julho
Contact Information
Study Contact:
Luciana M Sampaio, Dra
+55011996002075
lucianamalosa@gmail.com
Emilia R Nascimento
+55019997924782
ernemilia@gmail.com
Interventions
  • Other: Photobiomodulation — 1\. Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature. Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:\*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator.
  • Other: Exercise — Supervised Physical Training: The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring.
Study Locations (1 sites)
Uninove, São Paulo, São Paulo 01525000 Brazil
Eligibility Criteria
Critérios de Inclusão: Crianças em idade escolar de 6 a 17 anos Diagnosticado com asma leve a moderada (tratamento farmacológico regular) clinicamente estável Critérios de exclusão:Histórico de exacerbação da asma dentro de 30 dias antes do início do estudo, FAlha no preenchimento dos questionários
Investigation of the Effects of Oxidized Antigens on the T-Cell Response and the Epigenetic Reprogramming of Neutrophils in Lung Diseases - OXIGENE -
NCT07386912
Not yet recruiting
Conditions Asthma, COPD, Bacterial Pneumonia, Viral...
Phase Not Applicable
Enrollment 100
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-09-13
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Study Details Design, interventions, and primary outcomes

About This Study

The OXIGENE study is a research project that aims to better understand how the immune system behaves in people with lung diseases such as asthma, COPD, pneumonia, tuberculosis, and viral lung infections. By analyzing a single blood sample, the study examines how certain immune cells react during inflammation and infection, and whether lasting changes in these cells influence how strongly the body responds to disease. Although participants do not receive direct medical benefit, the results may help improve future diagnosis and treatment of lung diseases by providing deeper insight into immune responses.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: Characterization of the neutrophil granulocyte epigenome — Characterization of epigenomic differences in neutrophils from patients with different lung diseases (asthma, COPD, pneumonia, tuberculosis, and viral pulmonary infections such as COVID-19 and influenza) by identifying disease-specific epigenetic and functional signatures
  • Other: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens — Investigation of the response (activation/stimulation) of antigen-specific T cells from patients with tuberculosis to various oxidatively modified mycobacterial antigens, with the aim of determining whether changes in the redox status of these antigens measurably influence the adaptive immune response.

Primary Outcomes

  • Characterization of the neutrophil granulocyte epigenome (2030)
  • Characterization of functional signatures (2030)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-02-01
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Research Center Borstel
Principal Investigators:
  • Jan Heyckendorf, Prof. Dr. med. (PRINCIPAL_INVESTIGATOR) - University Hospital Schleswig-Holstein
Contact Information
Study Contact:
Tobias Dallenga, Dr. rer. nat.
+49 4537 188 5561
tdallenga@fz-borstel.de
Niklas Koehler, Dr. med.
+49 4537 188 8080
studienzentrum@fz-borstel.de
Interventions
  • Other: Characterization of the neutrophil granulocyte epigenome — Characterization of epigenomic differences in neutrophils from patients with different lung diseases (asthma, COPD, pneumonia, tuberculosis, and viral pulmonary infections such as COVID-19 and influenza) by identifying disease-specific epigenetic and functional signatures
  • Other: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens — Investigation of the response (activation/stimulation) of antigen-specific T cells from patients with tuberculosis to various oxidatively modified mycobacterial antigens, with the aim of determining whether changes in the redox status of these antigens measurably influence the adaptive immune response.
Study Locations (2 sites)
Medical Service Center MVZ, Research Center Borstel, Leibniz Lung Center, Borstel, Schleswig-Holstein 23845 Germany
Department of Pulmonology, University Hospital Schleswig-Holstein, Kiel, Schleswig-Holstein 24105 Germany
Eligibility Criteria
Inclusion Criteria: * Diagnosis of an acute or chronic inflammatory lung disease, infectious or non-infectious, including asthma, COPD, pneumonia, tuberculosis, or viral pulmonary infection (e.g., COVID-19, influenza). * Age ≥ 18 years at the time of informed consent. * Ability to provide informed consent and consent to the collection and processing of clinical and laboratory data, as well as to the analysis of blood samples as part of study participation. * Sufficient physical condition to undergo a single venous blood draw (approximately 50 mL), as assessed by the treating physician. Exclusion Criteria: * Active malignant disease or ongoing cancer therapy (e.g., chemotherapy or immunotherapy), due to potential immunological confounding. * Immunosuppressive therapy or known severe immunodeficiency that could interfere with the interpretation of cellular immune responses. * Pregnancy or breastfeeding, for general research-ethical reasons and to protect vulnerable populations. * Acute unstable clinical condition that, in the opinion of the treating physician, makes study participation unreasonable. * Known intolerance to blood sampling or relevant hematological disorders that could compromise the safety or feasibility of venipuncture. * Lack of capacity to provide informed consent or insufficient understanding of the study content despite supportive explanation.