Characterization of Adults for Asthma Microbiome Research Studies

NCT02887911 | Completed DMC

• 2 other identifiers: HUM000971635R01AI129958
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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"

Other Outcomes (3)

• To apply culture and molecular methods to study functions of asthma-associated airway microbiota in corticosteroid-enriched environments

  Day 1" for the first one and "up to 60 days"

• To evaluate the temporal stability of the airway microbiome in asthmatic and healthy subjects

  Day 1" for the first one and "up to 60 days"

• To explore relationships between airway and gut microbiome composition in asthma, including among obese subjects

  Day 1" for the first one and "up to 60 days"

Study Arms (4)

Asthmatic, not taking inhaled steroids

Men/Women, ages 18-75 who are not currently taking corticosteroids.. No intervention; this is a prospective observational study.

Asthmatic, taking inhaled steroids

Men/Women, ages 18-75 who are already taking corticosteroids prescribed by their physician. No intervention; this is a prospective observational study.

Healthy, non-asthmatic without allergies

Men/Women, ages 18-75 without a current diagnosis of asthma and no allergies. No intervention; this is a prospective observational study.

Healthy, atopic non-asthmatic

Men/Women, ages 18-75 with allergies but without a current diagnosis of asthma. No intervention; this is a prospective observational study.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A cohort of well characterized asthmatic subjects and a cohort of healthy people without asthma.

You may qualify if:

• \- Men/Women, ages 18-75, with or without current asthma, are eligible to be screened.

You may not qualify if:

• Cigarette smoking history of \>30 total pack-years
• Current use of other smoked products or recreational drugs (e.g. pipes, cigars, e-cigarettes, other illicit drugs)
• History of lung disease other than asthma
• Recent upper respiratory tract infection treated with antibiotics within 8 weeks of visit 1
• Recent antibiotic use (except topical or ocular) within 8 weeks of visit 1 (chronic antibiotic use for asthma management allowed)
• Currently pregnant or breast-feeding
• Other medical conditions or treatments that may increase subject risk or affect study results, based on study physician judgment. These include the following: significant cardiovascular disease(+/- active symptoms), arrhythmia, or stroke, active cancer, post-organ transplant
• Any other condition for which subject is taking immunosuppressive therapies (except steroids for asthma)
• History of allergy to albuterol or methacholine
• For asthma subjects only:
• Note: Enrollment target is for 90 asthmatics already taking inhaled corticosteroids prescribed by their physician (any formulation and dose) and 60 subjects who are not currently using inhaled corticosteroid.
• History of asthma symptoms within the last 2 years (e.g. wheeze, shortness of breath, etc.)
• Evidence of stable asthma as assessed by initial screening
• No changes in asthma medications within 30 days of visit 1
• Methacholine PC20 (dose at which there is a 20 percent change) ≤ 8 mg/ml (for those asthmatics on inhaled steroids, PC20 ≤ 16 mg/ml), or change in FEV1 (forced expiratory volume in first second of spirometry effort)≥ 12% after 4 puffs of albuterol on reversibility testing (or PI discretion)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen samples will be retained indefinitely in a coded manner. It is anticipated that samples from this research study will be used in future research projects.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yvonne J. Huang, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 2, 2016
• Study Start: December 22, 2015
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)