Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive Clinical Assessment.
- Who it may be relevant to
- Registry conditions: Asthma (Diagnosis), Chronic Obstructive Pulmonary Disease (COPD), Chronic Airway Diseases. Basic parameters: 20 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational Study for the Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases
Overview
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.
Detailed description
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.
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 ni
Primary outcome measures
- Distribution of Dyspnea Perception Scores [Time frame: Baseline]
- Clinical Phenotypes Based on Dyspnea Perception [Time frame: Through study completion, an average of 3 years]
Eligibility criteria
Inclusion criteria
- Inclusion Criteria for Chronic Airway Disease Patients:
- Age 20-75 years.
- 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.
- Willing and able to provide informed consent.
- Inclusion Criteria for Healthy Controls:
- Age ≥20 years.
- No history of asthma symptoms or diagnosis of chronic respiratory diseases such as asthma or COPD.
- Willing and able to provide informed consent and comply with the study protocol.
Exclusion criteria
- (applies to all participants):
- Respiratory tract infection, COPD acute exacerbation, or asthma acute exacerbation within the past 3 months.
- Presence of other diseases causing significant lung tissue destruction, such as severe bronchiectasis or tuberculosis.
- History of thoracic or abdominal surgery within the past 3 months.
- Heart rate >120 beats per minute.
- Ongoing anti-tuberculosis treatment.
- Presence of other severe, uncontrolled systemic diseases.
- Pregnant or lactating women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Chao-Yang Hospital — Beijing
Identifiers
NCT: NCT07472738 · Ybsz2025001 · Ybsz2025001