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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-75
SponsorBeijing Chao Yang Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Comprehensive Clinical Assessment

    Other intervention

    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.

Treatment groups

950 Participants
are divided into 2 treatment groups
Group A: Chronic Airway Diseases Cohort1 intervention
Group B: Healthy Control Cohort1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline
2

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

Time frame
Through study completion, an average of 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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