Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment

Summary

There are new, very sensitive methods for detecting bacteria. These methods show that hundreds of millions of microbes (organisms that can only be seen with microscopes), especially bacteria, live in healthy people. The collection of different microbes found in a site is called a "microbiome." The investigators know that microbiomes of the skin, sinuses, mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome - which bacteria are found in a site - may be necessary for good health. For example, the microbiome of the mouth is different in people with inflammation of the gums (periodontitis), and the microbiome of the bowel is different in people with inflammation of the intestinal tract (inflammatory bowel disease).

The purpose of this research study is to find out if the microbiome in the lungs is different in healthy people without asthma compared to people with asthma. This study will also find out if the microbiome of the lungs changes when people with asthma take a daily "controller" medication called an inhaled corticosteroid.

Conditions

• Asthma
• Atopy

Interventions

DRUG

fluticasone

Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day

DRUG

Placebo

Dry Powder Inhaler: Placebo

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Elliot Israel, MD · Brigham and Women's Hospital

• Lewis Smith, MD · Northwestern Memorial Hospital

• Richard Martin, MD · National Jewish Health

• Mario Castro, MD · Washington University School of Medicine

• Monica Kraft, MD · Duke University

• Stephen Peters, MD · Wake Forest University Health Sciences

• Homer Boushey, MD · University of California, San Francisco

• Sally Wenzel, MD · University of Pittsburgh Medical Center

• Christine Sorkness, MD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• United States

Study Locations