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NCT Number: NCT07472738

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.

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Key information

Conditions

Asthma (Diagnosis) Asthma Bronchial Diseases Chronic Airway Diseases Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shuya Huang, M.D.

CONTACT

[email protected]

+8617852063100

ZIxuan Wu, Master

CONTACT

[email protected]

+8617734128891

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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