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NCT Number: NCT04706988

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Treatment of asthma according to GINA guideline

Other

Pharmacological treatment depending on level of control of asthma

Primary outcomes

  1. 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.

Secondary outcomes

  1. disease severity

    Time frame: 12 months

    GINA treatment steps

  2. Asthma control

    Time frame: 12 months

    Level of asthma control

  3. Lung function

    Time frame: 12 months

    FEV1 % predicted

  4. endotype (eosinophilic vs neutrophilic asthma)

    Time frame: 12 months

    Blood eosinophil and IgE level

Study contacts

Contact information is provided by the study sponsor or research team.

David Hui, MD

CONTACT

[email protected]

+852 35053133

Fanny Ko, MD

CONTACT

[email protected]

+852 35053133

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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