Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 2:51 AM
Study NCT ID:
NCT01537133
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2012-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dtm5@psu.edu', 'phone': '717-531-7178', 'title': 'David Mauger', 'organization': 'Penn State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse events were not collected or assessed for healthy controls or atopic non-asthmatics', 'eventGroups': [{'id': 'EG000', 'title': 'Inhaled Corticosteroid', 'description': 'Fluticasone (250 mcg/puff, one puff, twice a day)', 'otherNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo fluticasone (one puff, twice a day)', 'otherNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Acute nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD 9'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Microbial Community Richness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atopic Asthmatics Treated With Inhaled Corticosteroids'}, {'id': 'OG001', 'title': 'Atopic Asthmatics Treated With Placebo'}, {'id': 'OG002', 'title': 'Atopic Non-asthmatics'}, {'id': 'OG003', 'title': 'Healthy Control'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '449', 'groupId': 'OG000', 'lowerLimit': '376', 'upperLimit': '613'}, {'value': '543', 'groupId': 'OG001', 'lowerLimit': '484', 'upperLimit': '684'}, {'value': '483', 'groupId': 'OG002', 'lowerLimit': '437', 'upperLimit': '646'}, {'value': '444', 'groupId': 'OG003', 'lowerLimit': '400', 'upperLimit': '530'}]}]}, {'title': 'after 6 weeks of treatment', 'categories': [{'measurements': [{'value': '456', 'groupId': 'OG000', 'lowerLimit': '351', 'upperLimit': '578'}, {'value': '405', 'groupId': 'OG001', 'lowerLimit': '385', 'upperLimit': '714'}, {'value': 'NA', 'comment': 'Only baseline data was collected from atopic non-asthmatics and healthy controls', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Only baseline data was collected from atopic non-asthmatics and healthy controls', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and after 6 weeks of treatment', 'description': 'Richness is the total number of different bacterial taxa detected in the sample.', 'unitOfMeasure': 'number of bacterial taxa', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Microbial Community Diversity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atopic Asthmatics Treated With Inhaled Corticosteroids'}, {'id': 'OG001', 'title': 'Atopic Asthmatics Treated With Placebo'}, {'id': 'OG002', 'title': 'Atopic Non-asthmatics'}, {'id': 'OG003', 'title': 'Healthy Control'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '5.6'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '6.0'}, {'value': '5.6', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '6.0'}, {'value': '5.3', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '5.5'}]}]}, {'title': 'after 6 weeks of treatment', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '5.7'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '5.7'}, {'value': 'NA', 'comment': 'Only baseline data was collected from atopic non-asthmatics and healthy controls', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Only baseline data was collected from atopic non-asthmatics and healthy controls', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and after 6 weeks of treatment', 'description': '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).', 'unitOfMeasure': 'Shannon Diversity Index', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Microbial Community Evenness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atopic Asthmatics Treated With Inhaled Corticosteroids'}, {'id': 'OG001', 'title': 'Atopic Asthmatics Treated With Placebo'}, {'id': 'OG002', 'title': 'Atopic Non-asthmatics'}, {'id': 'OG003', 'title': 'Healthy Control'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '0.90'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.79', 'upperLimit': '0.91'}, {'value': '0.90', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '0.94'}, {'value': '0.86', 'groupId': 'OG003', 'lowerLimit': '0.83', 'upperLimit': '0.91'}]}]}, {'title': 'after 6 weeks of treatment', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '0.90'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.81', 'upperLimit': '0.88'}, {'value': 'NA', 'comment': 'Only baseline data was collected from atopic non-asthmatics and healthy controls', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Only baseline data was collected from atopic non-asthmatics and healthy controls', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and after 6 weeks of treatment', 'description': "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.", 'unitOfMeasure': "Pielou's evenness index", 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inhaled Corticosteroid', 'description': 'Fluticasone (250 mcg/puff, one puff, twice a day)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo fluticasone (one puff, twice a day)'}, {'id': 'FG002', 'title': 'Healthy Control'}, {'id': 'FG003', 'title': 'Atopic Non-asthmatics'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Healthy controls and non-atopic asthmatics assessed only at baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Atopic Asthmatics Treated With Inhaled Corticosteroid', 'description': 'Fluticasone (250 mcg/puff, one puff, twice a day)'}, {'id': 'BG001', 'title': 'Atopic Asthmatics Treated With Placebo', 'description': 'Placebo fluticasone (one puff, twice a day)'}, {'id': 'BG002', 'title': 'Atopic Non-asthmatics'}, {'id': 'BG003', 'title': 'Healthy Control'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '40'}, {'value': '37', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '40'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '42'}, {'value': '28', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '45'}, {'value': '30', 'groupId': 'BG004', 'lowerLimit': '25', 'upperLimit': '42'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic or Latio', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Forced Expiratory Volume in 1 second', 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000', 'lowerLimit': '76', 'upperLimit': '99'}, {'value': '84', 'groupId': 'BG001', 'lowerLimit': '77', 'upperLimit': '89'}, {'value': '98', 'groupId': 'BG002', 'lowerLimit': '89', 'upperLimit': '108'}, {'value': '100', 'groupId': 'BG003', 'lowerLimit': '94', 'upperLimit': '107'}, {'value': '96', 'groupId': 'BG004', 'lowerLimit': '86', 'upperLimit': '105'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent of predicted', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Blood Eosinophils', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'BG000', 'lowerLimit': '1.3', 'upperLimit': '5.7'}, {'value': '3.6', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4.8'}, {'value': '2.0', 'groupId': 'BG002', 'lowerLimit': '1.4', 'upperLimit': '2.9'}, {'value': '1.4', 'groupId': 'BG003', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'BG004', 'lowerLimit': '1.2', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent of cells in blood sample', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sputum eosinophils', 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'BG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}, {'value': '0.7', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '1.5'}, {'value': '0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '0.45'}, {'value': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '0.4'}, {'value': '0.2', 'groupId': 'BG004', 'lowerLimit': '0.0', 'upperLimit': '0.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent of cells in sputum sample', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2012-02-09', 'resultsFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-17', 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial Community Richness', 'timeFrame': 'baseline and after 6 weeks of treatment', 'description': 'Richness is the total number of different bacterial taxa detected in the sample.'}, {'measure': 'Microbial Community Diversity', 'timeFrame': 'baseline and after 6 weeks of treatment', 'description': '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).'}, {'measure': 'Microbial Community Evenness', 'timeFrame': 'baseline and after 6 weeks of treatment', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma', 'Atopy']}, 'referencesModule': {'references': [{'pmid': '32298699', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAsthmatic:\n\n* History of physician-diagnosed asthma.\n* Methacholine PC20 \\< 8mg/ml and/or FEV1 improvement ≥ 12% in response to 180 mcg albuterol.\n* FEV1 ≥ 70% of predicted after 180 mcg albuterol.\n* Stable asthma for ≥ 3 months prior to enrollment (no urgent care visits, no systemic corticosteroid treatment).\n* Asthma Control Questionnaire 6 Score \\< 1.5.\n* Able to provide informed consent.\n* Able to perform spirometry as per ATS criteria.\n* Evidence by allergen skin test of sensitivity to an aeroallergen.\n* Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.\n\nHealthy Control:\n\n* Evidence by allergen skin test of sensitivity to an aeroallergen.\n* Able to provide informed consent.\n* Able to perform spirometry as per ATS criteria.\n\nExclusion Criteria:\n\nAsthmatic:\n\n* Presence of lung disease other than asthma.\n* Use of \\> 10 doses of nasal corticosteroids in the previous 3 months.\n* 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.\n* History of atrial or ventricular tachyarrhythmia.\n* Changes suggestive of cardiac ischemia on ECG at baseline.\n* History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.\n* History of chronic sinus disease.\n* Smoking \\> 5 pack-years, or within the past year\n* History of long-term controller medication use for asthma (inhaled or oral corticosteroid, leukotriene pathway antagonist, cromolyn, or theophylline within the preceding 6 months.\n* History of bleeding disorder.\n* Reduced creatinine clearance.\n* Inability, in the opinion of the Study Investigator, to coordinate use of inhaler or otherwise comply with medication regimens.\n* Contraindication to bronchoscopy on history or examination.\n\nHealthy Control:\n\n* History of chronic respiratory disease including asthma.\n* 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.\n* History of atrial or ventricular tachyarrhythmia.\n* Changes suggestive of cardiac ischemia on ECG at baseline.\n* History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.\n* Methacholine PC20 \\< 16 mg/ml or FEV1 improvement ≥ 12% in response to albuterol.\n* History of chronic sinus disease\n* Smoking \\> 5 pack-years, or within the past year\n* Use of \\> 10 doses of a nasal corticosteroid preparation in the previous 3 months\n* FEV1 or FVC \\< 80% predicted.\n* History of bleeding disorder.\n* Reduced creatinine clearance.\n* Contraindication to bronchoscopy on history or examination.'}, 'identificationModule': {'nctId': 'NCT01537133', 'briefTitle': 'Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment', 'orgStudyIdInfo': {'id': 'AsthmaNet 003'}, 'secondaryIdInfos': [{'id': 'U10HL098115', 'link': 'https://reporter.nih.gov/quickSearch/U10HL098115', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled corticosteroid', 'description': 'Fluticasone (250 mcg/puff, one puff, twice a day)', 'interventionNames': ['Drug: fluticasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo fluticasone (one puff, twice a day)', 'interventionNames': ['Drug: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Control'}, {'type': 'NO_INTERVENTION', 'label': 'Atopic Non-asthmatics'}], 'interventions': [{'name': 'fluticasone', 'type': 'DRUG', 'otherNames': ['Flovent 250'], 'description': 'Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day', 'armGroupLabels': ['Inhaled corticosteroid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dry Powder Inhaler: Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143-0130', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco, Adult', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27110', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh, Adult', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '53972', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Elliot Israel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Lewis Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern Memorial Hospital'}, {'name': 'Richard Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}, {'name': 'Mario Castro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Monica Kraft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Stephen Peters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Homer Boushey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Sally Wenzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}, {'name': 'Christine Sorkness, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Public Health Sciences', 'investigatorFullName': 'dave mauger', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}