RecruitingRecruiting
Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases
NCT07472738 · Beijing Chao Yang Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
An Observational Study for the Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases
About this study
Participants: The study aims to enroll approximately 800 patients with physician-diagnosed COPD (according to GOLD 2022 criteria) or asthma (according to GINA 2022 criteria), aged 20-75 years, and 150 age-matched healthy controls.
Interventions/Assessments: No investigational interventions will be assigned. Participants will undergo comprehensive assessments at baseline and follow-up visits, including:
Dyspnea perception measurement (using standardized scales). Spirometry, lung volume, and diffusion capacity tests. Fractional exhaled nitric oxide (FeNO) measurement. Blood tests (including complete blood count, total IgE, allergen screening). Health-related quality of life questionnaires (CAT, mMRC, AQLQ, SGRQ). High-resolution computed tomography (HRCT) of the chest. Functional magnetic resonance imaging (fMRI) of the brain (in a subset of participants).
Data on exacerbations, comorbidities, and current medications will be collected.
Eligibility criteria
Inclusion Criteria:
* Inclusion Criteria for Chronic Airway Disease Patients:
1. Age 20-75 years.
2. Meets the diagnostic criteria for COPD according to the 2022 GOLD guidelines OR meets the diagnostic criteria for asthma according to the 2022 GINA guidelines.
3. Willing and able to provide informed consent.
* Inclusion Criteria for Healthy Controls:
1. Age ≥20 years.
2. No history of asthma symptoms or diagnosis of chronic respiratory diseases such as asthma or COPD.
3. Willing and able to provide informed consent and comply with the study protocol.
Exclusion Criteria:
* (applies to all participants):
1. Respiratory tract infection, COPD acute exacerbation, or asthma acute exacerbation within the past 3 months.
2. Presence of other diseases causing significant lung tissue destruction, such as severe bronchiectasis or tuberculosis.
3. History of thoracic or abdominal surgery within the past 3 months.
4. Heart rate \>120 beats per minute.
5. Ongoing anti-tuberculosis treatment.
6. Presence of other severe, uncontrolled systemic diseases.
7. Pregnant or lactating women.
Study design
Enrollment target: 950 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-05-07
Estimated completion: 2027-12
Last updated: 2026-03-16
Interventions
Other: Comprehensive Clinical Assessment
Primary outcomes
- • Distribution of Dyspnea Perception Scores (Baseline)
- • Clinical Phenotypes Based on Dyspnea Perception (Through study completion, an average of 3 years)
Sponsor
Beijing Chao Yang Hospital · other
Contacts & investigators
ContactShuya Huang, M.D. · contact · 17852063100@163.com · +8617852063100
ContactZIxuan Wu, Master · contact · 17734128891@163.com · +8617734128891
InvestigatorKewu Huang, M.D. · principal_investigator, Beijing Chao Yang Hospital
All locations (1)
Beijing Chao-Yang HospitalRecruiting
Beijing, Beijing Municipality, China