Classifying treatable traits and breathlessness perception in people with COPD or asthma

An Observational Study for the Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases

This project will try to group adults with COPD or asthma by how they perceive breathlessness and link those groups to blood tests, lung tests, questionnaires, and brain scans.

Quick facts

• Study type: Observational
• Enrollment: 950 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07472738 on ClinicalTrials.gov

What this trial studies

This observational project will enroll about 800 adults with physician-diagnosed COPD or asthma and 150 age-matched healthy controls to perform comprehensive clinical phenotyping. Participants will complete standardized dyspnea perception measures, spirometry, lung volumes, diffusion capacity, FeNO, blood tests (including CBC and IgE/allergen screening), HRCT, and health-related quality-of-life questionnaires at baseline and follow-up visits. A subset will undergo functional MRI of the brain to study neural correlates of breathlessness perception. No investigational treatments are given; the aim is to identify subtypes based on perception and their relationships to other treatable characteristics and outcomes.

Who should consider this trial

Good fit: Adults aged 20–75 with physician-diagnosed COPD (GOLD 2022) or asthma (GINA 2022) who can provide consent and attend lung tests, blood draws, questionnaires and an optional brain MRI are ideal candidates.

Not a fit: People with recent respiratory exacerbations or infections, major lung-destructive diseases (e.g., severe bronchiectasis or active tuberculosis), recent thoracic/abdominal surgery, a heart rate over 120 bpm, or who cannot undergo MRI or the required testing are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help tailor treatments to patient subtypes and improve symptom management by targeting specific treatable traits.

How similar studies have performed: Previous research has described variable dyspnea perception and treatable traits in airway disease, but combining large-scale clinical phenotyping with brain fMRI in this way is relatively novel.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Chao-Yang Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Kewu Huang, M.D. — Beijing Chao Yang Hospital
• Study coordinator: Shuya Huang, M.D.

Conditions Asthma; Chronic Obstructive Pulmonary Disease; Chronic Airway Diseases; Treatable Traits; Dyspnea Perception; Clinical Phenotyping; Observational Study; Functional Magnetic Resonance Imaging