Asthma (Diagnosis)NCT07472738
Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases
An observational study of Asthma (Diagnosis) and Chronic Obstructive Pulmonary Disease (COPD), run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma (Diagnosis), Chronic Obstructive Pulmonary Disease (COPD), Chronic Airway Diseases
- What is being tested?
- Comprehensive Clinical Assessment
- How many people
- 950 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2025to Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality
Shuya Huang, M.D., +8617852063100, 17852063100@163.com
Zixuan Wu, Master, +8617734128891, 17734128891@163.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Comprehensive Clinical Assessment
- Keywords
- Treatable Traits, Dyspnea Perception, Clinical Phenotyping, Observational Study, Functional Magnetic Resonance Imaging (fMRI)
- Medical subject headings
- Asthma, Disease, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Clinical AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Airway Diseases Cohort | Patients with physician-diagnosed COPD or asthma Receives: Other: Comprehensive Clinical Assessment | |
| Healthy Control Cohort | Age-matched healthy volunteers without chronic respiratory diseases Receives: Other: Comprehensive Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start7 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kewu Huang, M.D., Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472738
- Sponsor's protocol ID
- Ybsz2025001
- Other IDs
- Ybsz2025001
- Status last verified
- May 2025
- First submitted
- 13 Nov 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study for the Investigation and Classification of Treatable Traits in Patients With Chronic Airway Diseases
- ClinicalTrials.gov ID
- NCT07472738
- Acronym / sponsor ID
- Ybsz2025001
- Keywords
- Treatable Traits, Dyspnea Perception, Clinical Phenotyping, Observational Study, Functional Magnetic Resonance Imaging (fMRI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Airway Diseases Cohort | – | Other: Comprehensive Clinical AssessmentPatients with physician-diagnosed COPD or asthma |
| Healthy Control Cohort | – | Other: Comprehensive Clinical AssessmentAge-matched healthy volunteers without chronic respiratory diseases |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
- (applies to all participants):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Clinical AssessmentThis 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. | Other | Chronic Airway Diseases Cohort, Healthy Control Cohort |
Primary outcome
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).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Asthma (Diagnosis)
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kewu Huang, M.D. principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma (Diagnosis) and Chronic Obstructive Pulmonary Disease (COPD), run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuya Huang, M.D. (+8617852063100, 17852063100@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Dyspnea Perception Scores (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.