Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-01-07 @ 7:41 AM
Study NCT ID:
NCT02230332
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alendronate to Prevent Loss of Bronchoprotection in Asthma
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': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmauger@psu.edu', 'phone': '717.531.3584', 'title': 'David Mauger, PhD', 'organization': 'Penn State University Dept of Public Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 9, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 13, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Esophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Acute nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Acue Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'asthma exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'Nausea alone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}], 'seriousEvents': [{'term': 'Viral Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}, {'term': 'GI Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ICD-9'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Salmeterol Protected Methacholine Challenge PC20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '2.5'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks after randomization', 'description': 'Following administration of Salmeterol, the concentration of Methacholine required to produce a 20% drop in FEV1 - measured in mg/ml and reported on log base 2 scale.', 'unitOfMeasure': 'mg/ml on log base 2 scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peripheral Blood Mononuclear Cell ADRB2 Cell Surface Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1680', 'groupId': 'OG000', 'lowerLimit': '1359', 'upperLimit': '2076'}, {'value': '1863', 'groupId': 'OG001', 'lowerLimit': '1473', 'upperLimit': '2358'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '8 weeks after randomization', 'unitOfMeasure': 'number of receptors per cell', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beta-2 Adrenergic Receptor Agonist-induced cAMP Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '7.5'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '7.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '8 weeks after randomization', 'description': 'Peripheral blood mononuclear cells cAMP concentrations measured using isoproterenol (ISO) as a beta-2 adrenergic receptor agonist, and using phosphate buffered saline (PBS) as a positive control. The outcome is expressed as the ratio of cAMP concentration using ISO relative to cAMP concentration using PBS.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Salivary Alpha Amylase Ratio (Post-Salmeterol / Pre-Salmeterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks after randomization', 'description': 'Salivary Alpha Amylase (sAA) levels from saliva samples obtained through passive drooling, before and 1 hour after Salmeterol administration. The outcome is expressed as the ratio of the Post-Salmeterol to the Pre-Salmeterol sAA levels.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Asthma Control Test (ACT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '23.2'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '21.4', 'upperLimit': '23.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks after randomization', 'description': 'Asthma Control Test : Score calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fractional Exhaled Nitrix Oxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '21.9'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '20.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '8 weeks after randomization', 'unitOfMeasure': 'parts per billion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eligible participants were recruited from the community between January 2015 and May 2016 at 9 U.S. sites from the NHLBI AsthmaNet research network.', 'preAssignmentDetails': 'Participants with persistent asthma were first treated with fluticasone propionate 250mcg twice daily for 2 weeks during the run-in. Most of the participants who were not randomized did not meet the Salmeterol Protected Methacholine Challenge inclusion criterion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily\n\nAlendronate'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo capsule taken once daily\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latio', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Asthma Control Test score', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '23'}, {'value': '21', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '23'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '23'}]}]}], 'paramType': 'MEAN', 'description': 'Asthma Control Test : Score calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'FEV1 - percent of predicted', 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '83.1', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '82.2', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent of predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Salmeterol Protected Methcholine PC20', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '1', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'description': 'During the challenge, the patient inhales methacholine aerosols in increasing concentrations. Spirometry is performed before and after each methacholine dose, and the results are reported as a percent decrease in FEV1 from baseline for each increasing dose of methacholine. A positive reaction to methacholine is a 20% fall in FEV1, and the provocative concentration that causes a positive reaction (the PC20) is used to indicate the level of airway hyperresponsiveness. Smaller numbers indicate greater airway hyperresponsiveness.', 'unitOfMeasure': 'mg/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2014-08-29', 'resultsFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-09', 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Salivary Alpha Amylase Ratio (Post-Salmeterol / Pre-Salmeterol)', 'timeFrame': '8 weeks after randomization', 'description': 'Salivary Alpha Amylase (sAA) levels from saliva samples obtained through passive drooling, before and 1 hour after Salmeterol administration. The outcome is expressed as the ratio of the Post-Salmeterol to the Pre-Salmeterol sAA levels.'}, {'measure': 'Asthma Control Test (ACT)', 'timeFrame': '8 weeks after randomization', 'description': 'Asthma Control Test : Score calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled.'}, {'measure': 'Fractional Exhaled Nitrix Oxide', 'timeFrame': '8 weeks after randomization'}], 'primaryOutcomes': [{'measure': 'Salmeterol Protected Methacholine Challenge PC20', 'timeFrame': '8 weeks after randomization', 'description': 'Following administration of Salmeterol, the concentration of Methacholine required to produce a 20% drop in FEV1 - measured in mg/ml and reported on log base 2 scale.'}], 'secondaryOutcomes': [{'measure': 'Peripheral Blood Mononuclear Cell ADRB2 Cell Surface Density', 'timeFrame': '8 weeks after randomization'}, {'measure': 'Beta-2 Adrenergic Receptor Agonist-induced cAMP Production', 'timeFrame': '8 weeks after randomization', 'description': 'Peripheral blood mononuclear cells cAMP concentrations measured using isoproterenol (ISO) as a beta-2 adrenergic receptor agonist, and using phosphate buffered saline (PBS) as a positive control. The outcome is expressed as the ratio of cAMP concentration using ISO relative to cAMP concentration using PBS.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '30872116', 'type': 'DERIVED', 'citation': 'Cardet JC, Jiang X, Lu Q, Gerard N, McIntire K, Boushey HA, Castro M, Chinchilli VM, Codispoti CD, Dyer AM, Holguin F, Kraft M, Lazarus S, Lemanske RF, Lugogo N, Mauger D, Moore WC, Moy J, Ortega VE, Peters SP, Smith LJ, Solway J, Sorkness CA, Sumino K, Wechsler ME, Wenzel S, Israel E; AsthmaNet Investigators. Loss of bronchoprotection with ICS plus LABA treatment, beta-receptor dynamics, and the effect of alendronate. J Allergy Clin Immunol. 2019 Aug;144(2):416-425.e7. doi: 10.1016/j.jaci.2019.01.049. Epub 2019 Mar 11.'}], 'seeAlsoLinks': [{'url': 'http://asthmanetresearch.org/', 'label': 'AsthmaNet home page'}]}, 'descriptionModule': {'briefSummary': 'Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller medication class in the United States, but unfortunately, even when LABAs are added to ICS and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use of beta-agonists, both short and long-acting, reduces the ability of these agents to protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor internalization, can reduce the loss of bronchoprotection that occurs with regular use of LABAs, even when used in combination with ICS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical history consistent with moderate asthma for \\>1 year\n* Asthma is controlled with ICS, with an FP dose ≤ 1000mcg/day and \\>100mcg/day (or equivalent)\n* Able to perform reproducible spirometry according to ATS criteria\n* Baseline FEV1 ≥ 50% of predicted and ≥1L.\n* If FEV1 \\<80%, a minimum 12% increase in FEV1 post-bronchodilator or a MCh PC20 ≤ 8 mg/mL\n* If FEV1 ≥80%, a MCh PC20 ≤ 8 mg/mL\n* Salmeterol protected MCh ≤ 16 mg/mL\n\nExclusion Criteria:\n\n* Uncontrolled asthma, as suggested by an ACT score \\<18 while on high-dose ICS (FP daily dose \\>500mcg or equivalent)\n* Non-ICS controller medication or LABA use within 4 weeks of study entry.\n* Contraindications to use of bisphosphonates: history of intolerance to bisphosphonates, history of esophageal ulcers, history of hematemesis, uncontrolled gastro-esophageal reflux disease, inability to stay erect for 30 minutes after oral drug, history of osteonecrosis of the jaw, dental extraction or root canal in prior 8 weeks, or anticipated during the study\n* Calculated GFR of less than 35 mL/min\n* History of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or \\> 10 pack-years total if ≥ 18 years of age\n* Systemic corticosteroid treatment for any condition within 4 weeks of enrollment at Visit 1, history of significant asthma exacerbation requiring systemic corticosteroids within 4 weeks of Visit 1 or more than five courses of systemic corticosteroids in the past year, history of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years\n* History of a respiratory tract infection within 4 weeks of Visit 1\n* Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment'}, 'identificationModule': {'nctId': 'NCT02230332', 'acronym': 'ALFA', 'briefTitle': 'Alendronate to Prevent Loss of Bronchoprotection in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Proof of Concept Study of Alendronate for Asthma', 'orgStudyIdInfo': {'id': 'AsthmaNet 009'}, 'secondaryIdInfos': [{'id': 'U10HL098115', 'link': 'https://reporter.nih.gov/quickSearch/U10HL098115', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alendronate', 'description': 'Alendronate in 10mg capsules taken once daily', 'interventionNames': ['Drug: Alendronate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule taken once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Alendronate', 'type': 'DRUG', 'otherNames': ['Fasomax'], 'armGroupLabels': ['Alendronate']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona College of Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Francisco', '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': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', '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': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '53972', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Juan Carlos Cardet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}]}, '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'}}}}