Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
This study is currently recruiting participants.
Verified December 2012 by Milton S. Hershey Medical Center
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01537133
First received: February 9, 2012
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma Atopy |
Drug: fluticasone Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment |
Resource links provided by NLM:
Further study details as provided by Milton S. Hershey Medical Center:
Primary Outcome Measures:
- microbial community composition [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 63 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Inhaled corticosteroid
Fluticasone (250 mcg/puff, one puff, twice a day)
|
Drug: fluticasone
Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day
Other Name: Flovent 250
|
|
Placebo Comparator: Placebo
Placebo fluticasone (one puff, twice a day)
|
Drug: Placebo
Dry Powder Inhaler: Placebo
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537133
Contacts
| Contact: David T Mauger, PhD | 717.531.7178 | dmauger@psu.edu |
Locations
| United States, California | |
| University of California, San Francisco, Adult | Recruiting |
| San Francisco, California, United States, 94143-0130 | |
| Principal Investigator: Homer Boushey, MD | |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Principal Investigator: Everett Sutherland, MD | |
| United States, Illinois | |
| Northwestern Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: Lewis Smith, MD | |
| United States, Massachusetts | |
| Brigham & Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Elliot Israel, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: Mario Castro, MD | |
| United States, North Carolina | |
| Duke University School of Medicine | Recruiting |
| Durham, North Carolina, United States, 27110 | |
| Principal Investigator: Monica Kraft, MD | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: Stephen Peters, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh, Adult | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: Sally Wenzel, MD | |
| United States, Wisconsin | |
| University of Wisconsin | Recruiting |
| Madison, Wisconsin, United States, 53972 | |
| Principal Investigator: Christine Sorkness, PharmD | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
| Principal Investigator: | Elliot Israel, MD | Brigham and Women's Hospital |
| Principal Investigator: | Lewis Smith, MD | Northwestern Memorial Hospital |
| Principal Investigator: | Richard Martin, MD | National Jewish Health |
| Principal Investigator: | Mario Castro, MD | Washington University School of Medicine |
| Principal Investigator: | Monica Kraft, MD | Duke University |
| Principal Investigator: | Stephen Peters, MD | Wake Forest University |
| Principal Investigator: | Homer Boushey, MD | University of California, San Francisco |
| Principal Investigator: | Sally Wenzel, MD | University of Pittsburgh |
| Principal Investigator: | Christine Sorkness, MD | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | dave mauger, Professor of Public Health Sciences, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01537133 History of Changes |
| Other Study ID Numbers: | AsthmaNet 003, U10HL098115 |
| Study First Received: | February 9, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013