AsthmaNCT06196034
Genetic Association With Various Severities, Phenotypes and Endotypes of Asthma.
An observational study of Asthma, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
There is limited information on genetics associated with asthma in Chinese. An earlier meta-analysis found that ADAM33, FcεRIb, RANTES, TNF-a, ACE, b2-AR, IL-4R and IL-13 genes could be proposed as asthma susceptible genes in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 2,000 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Mar 2024to 4 Jan 2029
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective observational study in outpatients with asthma seen and treated by physicians in the Prince of Wales Hospital. A total of 1000 asthma patients will be enrolled, along with 1000 controls matched for age, sex, and ethnicity.
Who may be able to join
- • All patients with confirmed diagnosis of asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable) 12
- Able to sign written informed consent form to participate in the study.
Who cannot join
- • Patients currently with acute exacerbation of asthma by GINA guideline. (For subjects with asthma exacerbation, they can join the study after 6 weeks post recovery from the exacerbation.)
- Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis(TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment.
- Patients currently diagnosed with pneumonia and acute bronchitis.
- For control subject: the inclusion will be having no clinical diagnosis of asthma.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, New Territories
David S Hui, MD, 35053133, dschui@cuhk.edu.hk
fanny WS Ko, MD, 35053133, fannyko@cuhk.edu.hk
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Fanny Ko, MD, fannyko@cuhk.edu.hk
David Hui, MD, dschui@cuhk.edu.hk
About this study
There is limited information on genetics associated with asthma in Chinese. An earlier meta-analysis found that ADAM33, FcεRIb, RANTES, TNF-a, ACE, b2-AR, IL-4R and IL-13 genes could be proposed as asthma susceptible genes in the Chinese population. However, given the limited number of studies, more data are required to validate these associations.
Future research must address key issues such as the broad clinical variability of asthma and the underrepresentation of populations of non-European heritage. Endotype-specific SNPs and unique biological insights may be obtained by conducting GWAS/EWAS on homogeneous populations of more therapy-resistant T2-low, adult-onset, obesity-associated asthma or asthma with particular co-morbidities.
The primary objective is to investigate the association between genetic polymorphisms and various severities of asthma.
Read the detailed description
Currently, many studies on asthma genetics are limited by the dominance of populations of European descent. In addition, there are few genetic studies that focus on moderate-to-severe asthma.
There is limited information on genetics associated with asthma in Chinese. An earlier meta-analysis found that ADAM33, FcεRIb, RANTES, TNF-a, ACE, b2-AR, IL-4R and IL-13 genes could be proposed as asthma susceptible genes in the Chinese population. However, given the limited number of studies, more data are required to validate these associations.
Future research must address key issues such as the broad clinical variability of asthma and the underrepresentation of populations of non-European heritage. Endotype-specific SNPs and unique biological insights may be obtained by conducting GWAS/EWAS on homogeneous populations of more therapy-resistant T2-low, adult-onset, obesity-associated asthma or asthma with particular co-morbidities.
Objectives Primary objective To investigate the association between genetic polymorphisms and various severities of asthma (e.g. mild, moderate, severe).
Secondary objectives
- Identify the most common genetic variants associated with asthma in Chinese patients.
- Determine the frequency and distribution of these genetic variants in Chinese patients compared to healthy controls.
- Explore the potential interactions between genetic and environmental factors in the development of asthma in Chinese patients.
- Explore the frequency and distribution of these genetic variants in patients with various phenotypes and endotypes (examples: including TH2 high asthma, Asthma COPD overlap, poor lung function, onset of illness)
This is a prospective observational study in outpatients with asthma seen and treated by physicians in the Prince of Wales Hospital. A total of 1000 asthma patients will be enrolled, along with 1000 controls matched for age, sex, and ethnicity. All participants will provide blood samples for genetic analysis, and clinical data will be collected from medical records and patient interviews. Genetic variants will be genotyped using high-throughput sequencing methods.
- Conditions
- Asthma
- Being tested
- No intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionGenetic
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Subjects with asthma Receives: Genetic: No intervention | |
| Control | Subjects with no asthma Receives: Genetic: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between genetic polymorphisms and various severities of asthma
association between genetic polymorphisms and various severities of asthma
Measured: 3 years
Secondary outcomes (2)
Identify the most common genetic variants associated with asthma in Chinese patients.
Identify the most common genetic variants associated with asthma in Chinese patients.
Measured: 3 years
Explore the frequency and distribution of these genetic variants in patients with various phenotypes and endotypes
Explore the frequency and distribution of these genetic variants in patients with various phenotypes and endotypes (examples: including TH2 high asthma, Asthma COPD overlap, poor lung function, onset of illness)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Mar 2024
- Primary completion4 Jan 2028 (estimated)
- Study completion4 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanny W.S. Ko, Chinese University of Hong Kong
- Investigators
- David SC Hui, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196034
- Sponsor's protocol ID
- Asthma Genetics_V2_08Aug2023
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We can share the data (no patient identity reviewed) if there are projects (with reasonable quality and request) requesting that according to the rules of our institution.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Association With Various Severities, Phenotypes and Endotypes of Asthma.
- ClinicalTrials.gov ID
- NCT06196034
- Acronym / sponsor ID
- Asthma Genetics_V2_08Aug2023
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 4 Jan 2028 (estimated)
- Study completion
- 4 Jan 2029 (estimated)
- First posted
- 9 Jan 2024 (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.
There is limited information on genetics associated with asthma in Chinese. An earlier meta-analysis found that ADAM33, FcεRIb, RANTES, TNF-a, ACE, b2-AR, IL-4R and IL-13 genes could be proposed as asthma susceptible genes in the Chinese population. However, given the limited number of studies, more data are required to validate these associations.
Future research must address key issues such as the broad clinical variability of asthma and the underrepresentation of populations of non-European heritage. Endotype-specific SNPs and unique biological insights may be obtained by conducting GWAS/EWAS on homogeneous populations of more therapy-resistant T2-low, adult-onset, obesity-associated asthma or asthma with particular co-morbidities.
The primary objective is to investigate the association between genetic polymorphisms and various severities of asthma.
Detailed description
Currently, many studies on asthma genetics are limited by the dominance of populations of European descent. In addition, there are few genetic studies that focus on moderate-to-severe asthma.
There is limited information on genetics associated with asthma in Chinese. An earlier meta-analysis found that ADAM33, FcεRIb, RANTES, TNF-a, ACE, b2-AR, IL-4R and IL-13 genes could be proposed as asthma susceptible genes in the Chinese population. However, given the limited number of studies, more data are required to validate these associations.
Future research must address key issues such as the broad clinical variability of asthma and the underrepresentation of populations of non-European heritage. Endotype-specific SNPs and unique biological insights may be obtained by conducting GWAS/EWAS on homogeneous populations of more therapy-resistant T2-low, adult-onset, obesity-associated asthma or asthma with particular co-morbidities.
Objectives Primary objective To investigate the association between genetic polymorphisms and various severities of asthma (e.g. mild, moderate, severe).
Secondary objectives
- Identify the most common genetic variants associated with asthma in Chinese patients.
- Determine the frequency and distribution of these genetic variants in Chinese patients compared to healthy controls.
- Explore the potential interactions between genetic and environmental factors in the development of asthma in Chinese patients.
- Explore the frequency and distribution of these genetic variants in patients with various phenotypes and endotypes (examples: including TH2 high asthma, Asthma COPD overlap, poor lung function, onset of illness)
This is a prospective observational study in outpatients with asthma seen and treated by physicians in the Prince of Wales Hospital. A total of 1000 asthma patients will be enrolled, along with 1000 controls matched for age, sex, and ethnicity. All participants will provide blood samples for genetic analysis, and clinical data will be collected from medical records and patient interviews. Genetic variants will be genotyped using high-throughput sequencing methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Genetic: No interventionSubjects with asthma |
| Control | – | Genetic: No interventionSubjects with no asthma |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study in outpatients with asthma seen and treated by physicians in the Prince of Wales Hospital. A total of 1000 asthma patients will be enrolled, along with 1000 controls matched for age, sex, and ethnicity.
Key inclusion criteria (2 listed)
- • All patients with confirmed diagnosis of asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable) 12
Key exclusion criteria (4 listed)
- • Patients currently with acute exacerbation of asthma by GINA guideline. (For subjects with asthma exacerbation, they can join the study after 6 weeks post recovery from the exacerbation.)
- For control subject: the inclusion will be having no clinical diagnosis of asthma.
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 |
|---|---|---|
| No interventionNo intervention | Genetic | Asthma, Control |
Primary outcome
association between genetic polymorphisms and various severities of asthma
Time frame: 3 years
association between genetic polymorphisms and various severities of asthma
2 secondary outcomes
Identify the most common genetic variants associated with asthma in Chinese patients.
Time frame: 3 years
Explore the frequency and distribution of these genetic variants in patients with various phenotypes and endotypes
Time frame: 3 years
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 18 Mar 2026.
- Individual participant dataSharing planned: Undecided. We can share the data (no patient identity reviewed) if there are projects (with reasonable quality and request) requesting that according to the rules of our institution.
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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.
David SC Hui study director
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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 2 inclusion and 4 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 18 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 2 sites in Hong Kong. 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 David SC Hui, MD (35053133, dschui@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between genetic polymorphisms and various severities of asthma (time frame: 3 years). 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 18 Mar 2026.