NCT04706988

Brief Summary

Increasing evidence supports that the respiratory microbiota, including viral and bacterial microorganisms, play important roles in respiratory health and disease. Microbial patterns in airways may induce distinctive endotypes of asthma. Previous studies suggest host-microbiota interactions in children may account for the heterogeneity of endotypes and clinical presentations. However, information on such relationship is limited in adults. Furthermore, how the upper airway microbiome is related to asthma endotype and phenotype is not well understood. Knowledge of microbiota in the airway allows exploration of therapeutic manipulation of the microbiome and targeting the development of asthma prevention strategies and the optimization of asthma treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2021Dec 2027

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

June 22, 2021

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

January 11, 2021

Last Update Submit

March 17, 2026

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Microbiome pattern

    The 16S data retrieved from the official website of HMP (http://www.hmpdacc.org/) will be used as the geographic reference for this study. Sequences assigned to different taxonomic levels, from phylum to genus using the RDP database, will be clustered into operating taxonomic units (OTUs) based on their best BLAST hit to reference type strain 16S DNAs at 98% sequence identity cutoff.

    12 months

Secondary Outcomes (4)

  • disease severity

    12 months

  • Asthma control

    12 months

  • Lung function

    12 months

  • endotype (eosinophilic vs neutrophilic asthma)

    12 months

Interventions

Treatment of asthma according to GINA guidelineOTHER

Pharmacological treatment depending on level of control of asthma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asthma subjects

You may qualify if:

  • Subjects aged between 18 and 80 years and have a diagnosis of asthma according to the Global Initiative for Asthma (GINA) document in 2020.
  • Asthma is 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 200 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable.

You may not qualify if:

  • Patients with respiratory diseases with other known respiratory diseases including chronic obstructive pulmonary disease, bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, history of lung resection and lung cancer
  • Individuals older than 40 years with a smoking history of more than 10 pack-years or significant biomass exposure
  • Patients currently randomized in other clinical studies
  • Pregnant women
  • Current smokers (who have not quit smoking in the past 1 year)
  • Systemic and intranasal antibiotics treatment within 4 weeks
  • Signs and symptoms of respiratory tract infections (upper or lower) within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal flock swab of asthma subjects. The swabs will be subjected to sequence analysis of 16S rRNA.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fanny Ko, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny Ko, MD

CONTACT

+852 35053133fannyko@cuhk.edu.hk

David Hui, MD

CONTACT

+852 35053133dschui@cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Associate Professor

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

June 22, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)