NCT06196034

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Mar 2024Jan 2029

First Submitted

Initial submission to the registry

December 23, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2029

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

December 23, 2023

Last Update Submit

March 17, 2026

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • association between genetic polymorphisms and various severities of asthma

    association between genetic polymorphisms and various severities of asthma

    3 years

Secondary Outcomes (2)

  • Identify the most common genetic variants associated with asthma in Chinese patients.

    3 years

  • Explore the frequency and distribution of these genetic variants in patients with various phenotypes and endotypes

    3 years

Study Arms (2)

Asthma

Subjects with asthma

Genetic: No intervention

Control

Subjects with no asthma

Genetic: No intervention

Interventions

No interventionGENETIC

No intervention

AsthmaControl

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, New Territories, Hong Kong

RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood for genetics study

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • David SC Hui

    Chinese University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

David SC Hui, MD

CONTACT

35053133dschui@cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 23, 2023

First Posted

January 9, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

January 4, 2028

Study Completion (Estimated)

January 4, 2029

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

HK(2)