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

March 12, 2026 updated by: Beijing Chao Yang Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Chao-Yang Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Airway Diseases Cohort
Patients with physician-diagnosed COPD or asthma
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.
Healthy Control Cohort
Age-matched healthy volunteers without chronic respiratory diseases
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of Dyspnea Perception Scores
Time Frame: Baseline
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
Time Frame: Through study completion, an average of 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Kewu Huang, M.D., Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ybsz2025001 (Other Grant/Funding Number: Beijing Institute of Respiratory Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A definitive plan for sharing individual participant data (IPD) has not been established for this study. The possibility of data sharing is under consideration and will be contingent upon obtaining approval from the institutional review board and ensuring compliance with local data privacy regulations. Further details will be specified in a future update to the registration record if a sharing plan is formalized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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