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| ID | Type | Description | Link |
|---|---|---|---|
| U10HL098115 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled corticosteroid | Experimental | Fluticasone (250 mcg/puff, one puff, twice a day) |
|
| Placebo | Placebo Comparator | Placebo fluticasone (one puff, twice a day) |
|
| Healthy Control | No Intervention | ||
| Atopic Non-asthmatics | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone | Drug | Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbial Community Richness | Richness is the total number of different bacterial taxa detected in the sample. | baseline and after 6 weeks of treatment |
| Microbial Community Diversity | The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i). | baseline and after 6 weeks of treatment |
| Microbial Community Evenness | Pielou's evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample. | baseline and after 6 weeks of treatment |
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Inclusion Criteria:
Asthmatic:
Healthy Control:
Exclusion Criteria:
Asthmatic:
Healthy Control:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Health Sciences | Principal Investigator |
| Homer Boushey, MD | University of California, San Francisco | Principal Investigator |
| Sally Wenzel, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Christine Sorkness, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco, Adult | San Francisco | California | 94143-0130 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32298699 | Derived | Durack J, Christian LS, Nariya S, Gonzalez J, Bhakta NR, Ansel KM, Beigelman A, Castro M, Dyer AM, Israel E, Kraft M, Martin RJ, Mauger DT, Peters SP, Rosenberg SR, Sorkness CA, Wechsler ME, Wenzel SE, White SR, Lynch SV, Boushey HA, Huang YJ; National Heart, Lung, and Blood Institute's "AsthmaNet". Distinct associations of sputum and oral microbiota with atopic, immunologic, and clinical features in mild asthma. J Allergy Clin Immunol. 2020 Nov;146(5):1016-1026. doi: 10.1016/j.jaci.2020.03.028. Epub 2020 Apr 13. |
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Healthy controls and non-atopic asthmatics assessed only at baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Corticosteroid | Fluticasone (250 mcg/puff, one puff, twice a day) |
| FG001 | Placebo | Placebo fluticasone (one puff, twice a day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Dry Powder Inhaler: Placebo |
|
| National Jewish Health |
| Denver |
| Colorado |
| 80206 |
| United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Duke University School of Medicine | Durham | North Carolina | 27110 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Pittsburgh, Adult | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Wisconsin | Madison | Wisconsin | 53972 | United States |
| FG002 | Healthy Control |
| FG003 | Atopic Non-asthmatics |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atopic Asthmatics Treated With Inhaled Corticosteroid | Fluticasone (250 mcg/puff, one puff, twice a day) |
| BG001 | Atopic Asthmatics Treated With Placebo | Placebo fluticasone (one puff, twice a day) |
| BG002 | Atopic Non-asthmatics | |
| BG003 | Healthy Control | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Forced Expiratory Volume in 1 second | Median | Inter-Quartile Range | percent of predicted |
| |||||||||||||||
| Blood Eosinophils | Median | Inter-Quartile Range | percent of cells in blood sample |
| |||||||||||||||
| Sputum eosinophils | Median | Inter-Quartile Range | percent of cells in sputum sample |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Microbial Community Richness | Richness is the total number of different bacterial taxa detected in the sample. | Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples. | Posted | Median | Inter-Quartile Range | number of bacterial taxa | baseline and after 6 weeks of treatment |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Microbial Community Diversity | The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i). | Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples. | Posted | Median | Inter-Quartile Range | Shannon Diversity Index | baseline and after 6 weeks of treatment |
|
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| Primary | Microbial Community Evenness | Pielou's evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample. | Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples. | Posted | Median | Inter-Quartile Range | Pielou's evenness index | baseline and after 6 weeks of treatment |
|
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Adverse events were not collected or assessed for healthy controls or atopic non-asthmatics
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Corticosteroid | Fluticasone (250 mcg/puff, one puff, twice a day) | 0 | 28 | 2 | 28 | ||
| EG001 | Placebo | Placebo fluticasone (one puff, twice a day) | 0 | 14 | 2 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute nasopharyngitis | Respiratory, thoracic and mediastinal disorders | ICD 9 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Mauger | Penn State University | 717-531-7178 | dtm5@psu.edu |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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| Black |
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| Hispanic or Latio |
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| Other |
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| after 6 weeks of treatment |
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| Participants |
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| Participants |
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