Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
Completed · Not applicable · Has a placebo group
Conditions studied: Asthma, Atopy
In brief
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.
Key facts
- Study ID
- NCT01537133
- Run by
- Milton S. Hershey Medical Center
- People needed
- 84
- Starts
- 2012-10-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2016-11-30
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of California, San Francisco, Adult — San Francisco, California, United States
- National Jewish Health — Denver, Colorado, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- Washington University — St Louis, Missouri, United States
- Duke University School of Medicine — Durham, North Carolina, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- University of Pittsburgh, Adult — Pittsburgh, Pennsylvania, United States
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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