Recruiting

Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases

ClinicalTrials.gov IDNCT07472738

PhaseNot Applicable

Enrollment950

SponsorBeijing Chao Yang Hospital

Age20 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma (Diagnosis), Chronic Obstructive Pulmonary Disease (COPD), Chronic Airway Diseases

About this study

This research study focuses on chronic airway diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. These conditions make it difficult for patients to breathe, but breathing difficulty (dyspnea) is often perceived very differently. Some patients may feel severe distress with mild breathing problems, while others might not notice significant breathing issues even when lung function is poor. This difference in perception is termed "dyspnea perception." The main goal of this study is to understand how dyspnea perception varies among patients with chronic airway diseases. The investigators aim to determine if patients can be grouped into different subtypes based on the perception of breathing difficulties. The study will also investigate how these subtypes relate to other treatable characteristics, such as blood cell counts, allergy test results, and findings from lung function tests and brain scans. Approximately 800 patients with COPD or asthma and 150 healthy volunteers will participate. Participants will answer questionnaires, undergo lung function tests, provide blood samples, and a subset will undergo a special brain scan (functional MRI). No new treatments will be assigned; instead, these characteristics will be observed and measured over time. It is hoped that this study will help doctors better understand chronic airway diseases and lead to more personalized management strategies for patients in the future.

Interventions

Other: Comprehensive Clinical Assessment — This is an observational study. No interventional treatment is assigned. Participants will undergo a comprehensive clinical assessment protocol, which includes: Measurement of dyspnea perception using standardized scales. Spirometry, lung volume, and diffusion capacity tests. Blood sample collection for complete blood count, total IgE, and allergen-specific IgE screening. Completion of quality of life and respiratory symptom questionnaires (e.g., CAT, mMRC, SGRQ, AQLQ). Fractional exhaled nitric oxide (FeNO) measurement. High-resolution computed tomography (HRCT) of the chest. Functional magnetic resonance imaging (fMRI) of the brain (for a subset of participants). Data on exacerbation history, comorbidities, and current medications will also be collected.

Primary outcomes

Distribution of Dyspnea Perception Scores (Baseline)
Clinical Phenotypes Based on Dyspnea Perception (Through study completion, an average of 3 years)

Eligibility information

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 locations

Beijing Chao-Yang Hospital, Beijing, Beijing Municipality China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.