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

NCT07472738 | Recruiting

• 1 other identifier: Ybsz2025001
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Treatable Traits; Dyspnea Perception; Clinical Phenotyping; Observational Study; Functional Magnetic Resonance Imaging (fMRI)

Outcome Measures

Primary Outcomes (2)

• Distribution of Dyspnea Perception Scores

  The distribution of dyspnea perception scores at baseline in the chronic airway disease cohort, as measured by the Borg Category-Ratio 10 (CR10) Scale (range 0-10, where higher scores indicate more severe dyspnea) or the Visual Analog Scale (VAS) (range 0-100 mm, where higher scores indicate a worse outcome/greater breathing difficulty).

  Baseline

• Clinical Phenotypes Based on Dyspnea Perception

  Identification of distinct clinical phenotypes derived from cluster analysis of dyspnea perception scores in combination with other clinical traits and biomarkers

  Through study completion, an average of 3 years

Study Arms (2)

Chronic Airway Diseases Cohort

Patients with physician-diagnosed COPD or asthma

Other: Comprehensive Clinical Assessment

Healthy Control Cohort

Age-matched healthy volunteers without chronic respiratory diseases

Other: Comprehensive Clinical Assessment

Interventions

Comprehensive Clinical Assessment OTHER

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.

Chronic Airway Diseases Cohort; Healthy Control Cohort

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of two groups: 1) a patient cohort of approximately 800 individuals with chronic airway diseases (Chronic Obstructive Pulmonary Disease or Asthma) recruited from hospital clinics and community screening; and 2) a control cohort of approximately 150 healthy volunteers. All participants will be aged between 20 and 75 years.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected and retained for the analysis of routine clinical biomarkers, including complete blood count, allergen-specific IgE screening, and total IgE levels. The samples will not be used for genetic (DNA) analysis.

MeSH Terms

Conditions

Asthma; Disease; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes

Study Officials

• Kewu Huang, M.D.

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuya Huang, M.D.

CONTACT

+8617852063100; 17852063100@163.com

ZIxuan Wu, Master

CONTACT

+8617734128891; 17734128891@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: March 16, 2026
• Study Start: May 7, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-05

Locations

CN (1)