AsthmaNCT04706988
Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma
An observational study of Asthma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Treatment of asthma according to GINA guideline
- How many people
- 140 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jun 2021to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma subjects
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Fanny WS KO, MD, fannyko@cuhk.edu.hk
David SC Hui, MD, dschui@cuhk.edu.hk
About this study
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.
Read the detailed description
This study plans to assess microbes in nasopharyngeal flock swab of asthma subjects. The swabs will be subjected to sequence analysis of 16S rRNA. Endotypes (e.g. TH1 vs TH2 inflammation) and phenotypes of the subjects (e.g. severity, exacerbation, lung function, etc.) will be assessed. The planned sample size is 140 adult asthma subjects. Patients will have nasopharyngeal swabs taken at baseline, 3 months (after optimization of asthma treatment at baseline) and at 1 year. They will undergo assessments, including clinical course, lung function, exhaled nitric oxide, skin test, and blood test (including eosinophils and immunoglobulin E levels). All subjects will be followed up for 2 years to assess subsequent exacerbations and levels of asthma control. 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 (ribosomal database project) database, will be clustered into operating taxonomic units (OTUs). Bioinformatic tools will be used to assess the relations of microbiota, asthma endotypes and phenotypes and change of microbiota pattern upon optimization of asthma drug treatment.
- Conditions
- Asthma
- Being tested
- Treatment of asthma according to GINA guideline
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of asthma according to GINA guidelineOther
Pharmacological treatment depending on level of control of asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
disease severity
GINA treatment steps
Measured: 12 months
Asthma control
Level of asthma control
Measured: 12 months
Lung function
FEV1 % predicted
Measured: 12 months
endotype (eosinophilic vs neutrophilic asthma)
Blood eosinophil and IgE level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start22 Jun 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 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
- Fanny Ko, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706988
- Sponsor's protocol ID
- Asthma microbiome_v01
- Status last verified
- Mar 2026
- First submitted
- 11 Jan 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma
- ClinicalTrials.gov ID
- NCT04706988
- Acronym / sponsor ID
- Asthma microbiome_v01
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2021 (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.
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.
Detailed description
This study plans to assess microbes in nasopharyngeal flock swab of asthma subjects. The swabs will be subjected to sequence analysis of 16S rRNA. Endotypes (e.g. TH1 vs TH2 inflammation) and phenotypes of the subjects (e.g. severity, exacerbation, lung function, etc.) will be assessed. The planned sample size is 140 adult asthma subjects. Patients will have nasopharyngeal swabs taken at baseline, 3 months (after optimization of asthma treatment at baseline) and at 1 year. They will undergo assessments, including clinical course, lung function, exhaled nitric oxide, skin test, and blood test (including eosinophils and immunoglobulin E levels). All subjects will be followed up for 2 years to assess subsequent exacerbations and levels of asthma control. 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 (ribosomal database project) database, will be clustered into operating taxonomic units (OTUs). Bioinformatic tools will be used to assess the relations of microbiota, asthma endotypes and phenotypes and change of microbiota pattern upon optimization of asthma drug treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma subjects
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Treatment of asthma according to GINA guidelinePharmacological treatment depending on level of control of asthma | Other | – |
Primary outcome
Microbiome pattern
Time frame: 12 months
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.
4 secondary outcomes
disease severity
Time frame: 12 months
Asthma control
Time frame: 12 months
Lung function
Time frame: 12 months
endotype (eosinophilic vs neutrophilic asthma)
Time frame: 12 months
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Fanny Ko, MD principal investigator
Chinese University of Hong Kong
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, run by Chinese University of Hong Kong at 1 site 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 7 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 19 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 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 Fanny Ko, MD (+852 35053133, fannyko@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome pattern (time frame: 12 months). 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 19 Mar 2026.