Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 5/5/2014 |
| Start Date: | October 2012 |
| End Date: | January 2014 |
| Contact: | David T Mauger, PhD |
| Email: | dmauger@psu.edu |
| Phone: | 717.531.7178 |
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.
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.
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.
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.
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.
We found this trial at
9
sites
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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