Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-04 @ 11:32 PM
Study NCT ID:
NCT02584257
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2015-10-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016210', 'term': 'Methacholine Chloride'}, {'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D008688', 'term': 'Methacholine Compounds'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marklepore@lupin.com', 'phone': '(443) 740-9323', 'title': 'Dr. Mark Lepore', 'organization': 'Lupin Research Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AE/SAEs (including treatment-emergent AEs) were assessed throughout the study visits and followed to resolution/satisfaction. AEs were recorded starting after the patient had signed the informed consent form and assessed at all visits. Each AE was evaluated for date/time of onset, duration, intensity, and causal relationship with the investigational product or other factors. (5 months) First Patient Screened: 12-Apr 2016 & Last Patient Visit: 12 Aug 2016', 'description': 'An AE was defined as any untoward medical occurrence in a clinical trial patient administered a medicinal product and which did not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not considered related to the investigational medicinal product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Dose', 'description': 'Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nplacebo Lupin albuterol HFA MDI', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 3, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '90 mcg ProAir HFA', 'description': '90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nProAir HFA\n\nplacebo Lupin albuterol HFA MDI', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 4, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '180 mcg ProAir HFA', 'description': '180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols\n\nmethacholine chloride\n\nProAir HFA\n\nplacebo Lupin albuterol HFA MDI', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 1, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '90 mcg Lupin Albuterol HFA MDI', 'description': '90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nLupin albuterol HFA MDI\n\nplacebo Lupin albuterol HFA MDI', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 8, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '180 mcg Lupin Albuterol HFA MDI', 'description': '180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nLupin albuterol HFA MDI', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 1, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Heart Rate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tension Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Dose', 'description': 'Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nplacebo Lupin albuterol HFA MDI N=82'}, {'id': 'OG001', 'title': '90 mcg ProAir HFA', 'description': '90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nProAir HFA\n\nplacebo Lupin albuterol HFA MDI'}, {'id': 'OG002', 'title': '180 mcg ProAir HFA', 'description': '180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols\n\nmethacholine chloride\n\nProAir HFA\n\nplacebo Lupin albuterol HFA MDI'}, {'id': 'OG003', 'title': '90 mcg Lupin Albuterol HFA MDI', 'description': '90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nLupin albuterol HFA MDI\n\nplacebo Lupin albuterol HFA MDI'}, {'id': 'OG004', 'title': '180 mcg Lupin Albuterol HFA MDI', 'description': '180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols\n\nmethacholine chloride\n\nplacebo ProAir HFA\n\nLupin albuterol HFA MDI'}], 'classes': [{'categories': [{'measurements': [{'value': '0.608', 'spread': '0.239', 'groupId': 'OG000'}, {'value': '3.779', 'spread': '0.238', 'groupId': 'OG001'}, {'value': '4.432', 'spread': '0.238', 'groupId': 'OG002'}, {'value': '3.928', 'spread': '0.241', 'groupId': 'OG003'}, {'value': '4.481', 'spread': '0.240', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Means Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.171', 'ciLowerLimit': '2.732', 'ciUpperLimit': '3.610', 'pValueComment': 'Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\\<0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'statisticalMethod': 'Brief Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Means Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.824', 'ciLowerLimit': '3.384', 'ciUpperLimit': '4.263', 'pValueComment': 'Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'statisticalMethod': 'Brief Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Square Means Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.320', 'ciLowerLimit': '2.876', 'ciUpperLimit': '3.764', 'pValueComment': 'Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.241', 'statisticalMethod': 'Brief Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Square Means Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.872', 'ciLowerLimit': '3.430', 'ciUpperLimit': '4.315', 'pValueComment': 'Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.240', 'statisticalMethod': 'Brief Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL'}, {'groupIds': ['OG001', 'OG002', 'OG003', 'OG004'], 'paramType': 'Frel', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.15', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'Frel is the relative bioavailability of the test versus reference product. The CI was a bias corrected and accelerated CI based on a bootstrapping procedure. The FDA acceptable CI was between 0.67 and 1.50.', 'groupDescription': 'An Emax model was developed and the 90% confidence interval of Frel was a bias corrected accelerated confidence interval based on a bootstrapping procedure. The bootstrapping procedure used for this analysis was residual resampling. The Per-Protocol population was the primary population for bioequivalence analysis. Patients in the PP population must have completed at least 2 treatment periods with valid PC20FEV1 measurements and had no major protocol deviations within those intervals.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'A blinded interim analysis was performed after 60 patients completed all treatment visits which determined that 80 subjects would be sufficient to complete the study with 90% power.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.', 'description': 'The primary efficacy endpoint was the postdose PC20 following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 was determined relative to the saline stage FEV1 measured before albuterol or placebo administration. Additionally, an analysis of superiority to placebo was performed for the T and R products prior to the BE determination. In this study the ITT and PP populations were identical.', 'unitOfMeasure': 'log(mg/mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population included all randomized patients who completed at least 2 treatment periods with valid PC20 FEV1 measurements.Treatment was assigned based upon treatment to which patients had been randomized regardless of which treatment they actually received. This was primary population for comparisons of T and R products to placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PBO-R90-T180-R180-T90', 'description': 'Subjects received PBO in period 1 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 2 (1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 3 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), R180 in period 4 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 5 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols)'}, {'id': 'FG001', 'title': 'R90-R180-PBO-T90-T180', 'description': 'Subjects received R90 in period 1 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 2 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 3 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 4 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), T180 in period 5 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols)'}, {'id': 'FG002', 'title': 'R180-T90-R90-T180-PBO', 'description': 'Subjects received R180 in period 1 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 2 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), R90 in period 3 (1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 4 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), PBO in period 5 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)'}, {'id': 'FG003', 'title': 'T90-T180-R180-PBO-R90', 'description': 'Subjects received T90 in period 1 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), T180 in period 2 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), R180 in period 3 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 4 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 5 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)'}, {'id': 'FG004', 'title': 'T180-PBO-T90-R90-R180', 'description': 'Subjects received T180 in period 1 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), PBO in period 2 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 3 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), R90 in period 4 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 5 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)'}, {'id': 'FG005', 'title': 'T90-R180-T180-R90-PBO', 'description': 'Subjects received T90 in period 1 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), R180 in period 2 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 3 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), R90 in period 4 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 5 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)'}, {'id': 'FG006', 'title': 'T180-T90-PBO-R180-R90', 'description': 'Subjects received T180 in period 1 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), T90 in period 2 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), PBO in period 3 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 4 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 5 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols)'}, {'id': 'FG007', 'title': 'R90-PBO-R180-T180-T90', 'description': 'Subjects received R90 in period 1 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), PBO in period 2 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R180 in period 3 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 4 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols), T90 in period 5 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols)'}, {'id': 'FG008', 'title': 'R180-R90-T90-PBO-T180', 'description': 'Subjects received R180 in period 1 (1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), R90 in period 2 (1 actuation each from tProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T90 in period 3 (1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols), PBO in period 4 (1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols), T180 in period 5 (1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols),'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Male/female patients 18-65 years of age, inclusive, with a diagnosis of asthma and at least a 6-month history of stable mild asthma as defined by the NAEPP EPR-3 guidelines were recruited and enrolled at 17 different centers in the USA. First subject was screened on April 12th, 2016 and the last patient was completed the study on August 12th, 2016.', 'preAssignmentDetails': 'Of the 217 patients enrolled in the study, 126 failed screening or were randomization failures, largely due to failure to meet the inclusion and exclusion criteria. 91 Subjects were randomized to treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety Population', 'description': 'All randomized patients who received a dose of any of the randomized study medications. Patient baseline characteristics are not designated by treatment arms due to the crossover design of the study (treatment groups are not mutually exclusive).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '11.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic/Latino', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The study was conducted in 17 study centers in the United States of America (USA)', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized patients who received a dose of any of the study medications.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2019-03-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2015-10-12', 'dispFirstSubmitQcDate': '2019-03-11', 'resultsFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2015-10-20', 'dispFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-23', 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo', 'timeFrame': 'Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.', 'description': 'The primary efficacy endpoint was the postdose PC20 following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 was determined relative to the saline stage FEV1 measured before albuterol or placebo administration. Additionally, an analysis of superiority to placebo was performed for the T and R products prior to the BE determination. In this study the ITT and PP populations were identical.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild Persistent Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.', 'detailedDescription': 'A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, 5-Treatment, Randomized, Crossover Study to Demonstrate the Pharmacodynamic Bioequivalence of Test and Reference Metered Dose Inhalers containing Albuterol Sulfate using Bronchoprovocation in Adult Patients with Stable Mild Asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and non-pregnant female subjects (18-65 years of age)\n* Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.\n* Forced Expiratory Volume in 1 second ( FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.\n* Nonsmokers for at least 1 year prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).\n* Written informed consent.\n\nExclusion Criteria:\n\n* Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, lower respiratory tract, viral bronchitis and/or sinobronchitis) within six weeks preceding the screening visit.\n* History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.\n* History of cystic fibrosis, bronchiectasis or other respiratory diseases.\n* History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, or chronic condition that could put the safety of the patient at risk during the study or affect the efficacy and safety analyses during the study.\n* Treatment in an emergency room, urgent care center, or hospitalization for acute asthmatic symptoms within the past 6 months or need for daily oral corticosteroids within past 3 months.\n* Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).'}, 'identificationModule': {'nctId': 'NCT02584257', 'briefTitle': 'Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lupin Ltd.'}, 'officialTitle': 'Comparison of the Pharmacodynamic Profile of Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Bronchoprovocation in Adult Patients With Stable Mild Asthma', 'orgStudyIdInfo': {'id': 'AS-MDI-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo dose', 'description': 'Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols', 'interventionNames': ['Other: methacholine chloride', 'Drug: placebo ProAir HFA', 'Drug: placebo Lupin albuterol HFA MDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': '90 mcg ProAir HFA', 'description': '90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols', 'interventionNames': ['Other: methacholine chloride', 'Drug: placebo ProAir HFA', 'Drug: ProAir HFA', 'Drug: placebo Lupin albuterol HFA MDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': '180 mcg ProAir HFA', 'description': '180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols', 'interventionNames': ['Other: methacholine chloride', 'Drug: ProAir HFA', 'Drug: placebo Lupin albuterol HFA MDI']}, {'type': 'EXPERIMENTAL', 'label': '90 mcg Lupin albuterol HFA MDI', 'description': '90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols', 'interventionNames': ['Other: methacholine chloride', 'Drug: placebo ProAir HFA', 'Drug: Lupin albuterol HFA MDI', 'Drug: placebo Lupin albuterol HFA MDI']}, {'type': 'EXPERIMENTAL', 'label': '180 mcg Lupin albuterol HFA MDI', 'description': '180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols', 'interventionNames': ['Other: methacholine chloride', 'Drug: placebo ProAir HFA', 'Drug: Lupin albuterol HFA MDI']}], 'interventions': [{'name': 'methacholine chloride', 'type': 'OTHER', 'armGroupLabels': ['180 mcg Lupin 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