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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537133
• Other study ID #: AsthmaNet 003
• Secondary ID: U10HL098115
• Status: Completed
• Phase: N/A
• First received: February 9, 2012
• Last updated: July 10, 2014
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Two broad specific aims of this study are: 1)To evaluate whether the microbiota of the bronchial airways in atopic asthmatics and atopic healthy controls differ in microbial diversity, richness, evenness, or composition of specific bacterial taxa. 2) To determine whether inhaled corticosteroid treatment alters bronchial microbial community composition in asthmatics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Asthmatic:

• History of physician-diagnosed asthma.

• Methacholine PC20 < 8mg/ml and/or FEV1 improvement = 12% in response to 180 mcg albuterol.

• FEV1 = 70% of predicted after 180 mcg albuterol.

• Stable asthma for = 3 months prior to enrollment (no urgent care visits, no systemic corticosteroid treatment).

• Asthma Control Questionnaire 6 Score < 1.5.

• Able to provide informed consent.

• Able to perform spirometry as per ATS criteria.

• Evidence by allergen skin test of sensitivity to an aeroallergen.

• Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.

Healthy Control:

• Evidence by allergen skin test of sensitivity to an aeroallergen.

• Able to provide informed consent.

• Able to perform spirometry as per ATS criteria.

Exclusion Criteria:

Asthmatic:

• Presence of lung disease other than asthma.

• Use of > 10 doses of nasal corticosteroids in the previous 3 months.

• Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.

• History of atrial or ventricular tachyarrhythmia.

• Changes suggestive of cardiac ischemia on ECG at baseline.

• History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.

• History of chronic sinus disease.

• Smoking > 5 pack-years, or within the past year

• History of long-term controller medication use for asthma (inhaled or oral corticosteroid, leukotriene pathway antagonist, cromolyn, or theophylline within the preceding 6 months.

• History of bleeding disorder.

• Reduced creatinine clearance.

• Inability, in the opinion of the Study Investigator, to coordinate use of inhaler or otherwise comply with medication regimens.

• Contraindication to bronchoscopy on history or examination.

Healthy Control:

• History of chronic respiratory disease including asthma.

• Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.

• History of atrial or ventricular tachyarrhythmia.

• Changes suggestive of cardiac ischemia on ECG at baseline.

• History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.

• Methacholine PC20 < 16 mg/ml or FEV1 improvement = 12% in response to albuterol.

• History of chronic sinus disease

• Smoking > 5 pack-years, or within the past year

• Use of > 10 doses of a nasal corticosteroid preparation in the previous 3 months

• FEV1 or FVC < 80% predicted.

• History of bleeding disorder.

• Reduced creatinine clearance.

• Contraindication to bronchoscopy on history or examination.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Asthma
• Atopy

Intervention

Drug:
• fluticasone
Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day
• Placebo
Dry Powder Inhaler: Placebo

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	Duke University School of Medicine	Durham	North Carolina
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Pittsburgh, Adult	Pittsburgh	Pennsylvania
United States	University of California, San Francisco, Adult	San Francisco	California
United States	Washington University	St. Louis	Missouri
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbial community composition	Descriptors of microbial community composition at baseline, and before and after ICS treatment intervention: Richness (number of different bacterial taxa identified); Evenness (distribution of the relative abundance of the taxa identified); Diversity (a function of richness and evenness); Presence and relative abundance of specific bacterial taxa	after 6 weeks of treatment	No