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| ID | Type | Description | Link |
|---|---|---|---|
| Ybsz2025001 | Other Grant/Funding Number | Beijing Institute of Respiratory Medicine |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Airway Diseases Cohort | Patients with physician-diagnosed COPD or asthma |
| |
| Healthy Control Cohort | Age-matched healthy volunteers without chronic respiratory diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Inclusion Criteria for Chronic Airway Disease Patients:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria:
(applies to all participants):
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuya Huang, M.D. | Contact | +8617852063100 | 17852063100@163.com | |
| ZIxuan Wu, Master | Contact | +8617734128891 | 17734128891@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kewu Huang, M.D. | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Recruiting | Beijing | Beijing Municipality | China |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2023 | Jan 26, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2023 | Mar 12, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004194 | Disease |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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.
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |