Characterization of Adults for Asthma Microbiome Research Studies

Completed

• Conditions: Healthy; Asthma

• Registration Number: NCT02887911
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to characterize adult subjects regarding their history of allergy and asthma, clinical manifestations of asthma, and exposures and conditions that may influence asthma severity and control. Assessments include baseline medical history, lung function tests, questionnaires, and collection of specimens for phenotypic characterization.

Detailed Description

This is a prospective, observational study in which approximately 200 subjects will be enrolled, including healthy controls, atopic controls without asthma, and patients with stable asthma (n = 150). Among asthmatics, 2/3 will be on regular inhaled corticosteroid therapy and 1/3 will not be taking inhaled corticosteroids. Subjects who meet study criteria will undergo phenotypic characterization in multiple domains, including evaluation of lung function, assessments of asthma/allergy history, asthma triggers, asthma symptom control, environmental microbial exposures and dietary intake. Oral rinse, sputum, stool, urine and blood specimens will be collected for microbiome-related analyses, including molecular and culture-based assays, metabolite studies, and to relate these to markers of inflammation and immune function. The overall goal is to enroll a cohort of well-characterized asthmatic and non-asthmatic control subjects to enable mechanism-oriented studies of how members of the airway microbiota and possibly also gut microbiota influence phenotypes of adult asthma.

Study Timeline

• Study Start: 2015-12-22
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize adult subjects with asthma in multiple domains, including disease severity and control, patterns of airway inflammation, microbial exposures and patterns of airway and gut microbial colonization	Day 1" for the first one and "up to 60 days"

Secondary Outcome Measures

Name	Time	Method
To evaluate differences in airway and gut microbiota composition related to inhaled corticosteroid use (ICS) among asthmatics already regularly taking ICS, asthmatics not taking ICS, and healthy controls	Day 1" for the first one and "up to 60 days"

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States