Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02796651
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2016-06-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialtransparency@astrazeneca.com', 'phone': '+46 766 346712', 'title': 'Global Clinical Leader', 'organization': 'AstraZeneca AB'}, 'certainAgreement': {'otherDetails': 'All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of signature of informed consent throughout the treatment period and including the follow-up period (i.e. 2 weeks after the last IP).', 'description': 'Adverse event: The development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram)', 'eventGroups': [{'id': 'EG000', 'title': 'Formoterol Fumarate 6 μg', 'description': 'Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 3, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Formoterol Fumarate (FF) 12 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 4, 'seriousNumAtRisk': 121, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Formoterol Fumarate (FF) 24 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 1, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Perforomist 20 μg', 'description': 'Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 7, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Perforomist 40 μg', 'description': 'Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 0, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Placebo (Lactose Monohydrate)', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 3, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'seriousEvents': [{'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Vascular stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol Fumarate 6 μg', 'description': 'Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days'}, {'id': 'OG001', 'title': 'Formoterol Fumarate (FF) 12 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG002', 'title': 'Formoterol Fumarate (FF) 24 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG003', 'title': 'Perforomist 20 μg', 'description': 'Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days'}, {'id': 'OG004', 'title': 'Placebo (Lactose Monohydrate)', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.108', 'groupId': 'OG000', 'lowerLimit': '0.073', 'upperLimit': '0.143'}, {'value': '0.117', 'groupId': 'OG001', 'lowerLimit': '0.082', 'upperLimit': '0.151'}, {'value': '0.161', 'groupId': 'OG002', 'lowerLimit': '0.125', 'upperLimit': '0.197'}, {'value': '0.122', 'groupId': 'OG003', 'lowerLimit': '0.087', 'upperLimit': '0.156'}, {'value': '0.000', 'groupId': 'OG004', 'lowerLimit': '-0.055', 'upperLimit': '0.054'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.108', 'ciLowerLimit': '0.055', 'ciUpperLimit': '0.161', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.117', 'ciLowerLimit': '0.064', 'ciUpperLimit': '0.171', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.162', 'ciLowerLimit': '0.107', 'ciUpperLimit': '0.216', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.122', 'ciLowerLimit': '0.069', 'ciUpperLimit': '0.175', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.009', 'ciLowerLimit': '-0.021', 'ciUpperLimit': '0.039', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.053', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.085', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.365', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.014', 'ciLowerLimit': '-0.016', 'ciUpperLimit': '0.044', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.044', 'ciLowerLimit': '0.013', 'ciUpperLimit': '0.076', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.756', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.005', 'ciLowerLimit': '-0.026', 'ciUpperLimit': '0.036', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.039', 'ciLowerLimit': '-0.071', 'ciUpperLimit': '-0.008', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg).\n\nPre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them.\n\nNote: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.', 'unitOfMeasure': 'Litre/Hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant's adherence to the randomized treatment."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol Fumarate 6 μg', 'description': 'Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days'}, {'id': 'OG001', 'title': 'Formoterol Fumarate (FF) 12 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG002', 'title': 'Formoterol Fumarate (FF) 24 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG003', 'title': 'Perforomist 20 μg', 'description': 'Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days'}, {'id': 'OG004', 'title': 'Perforomist 40 μg', 'description': 'Randomized participants received single dose of 2 vials of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning of Day 1 of assigned treatment period.'}, {'id': 'OG005', 'title': 'Placebo (Lactose Monohydrate)', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.111', 'groupId': 'OG000', 'lowerLimit': '0.077', 'upperLimit': '0.145'}, {'value': '0.148', 'groupId': 'OG001', 'lowerLimit': '0.115', 'upperLimit': '0.182'}, {'value': '0.205', 'groupId': 'OG002', 'lowerLimit': '0.171', 'upperLimit': '0.239'}, {'value': '0.195', 'groupId': 'OG003', 'lowerLimit': '0.162', 'upperLimit': '0.229'}, {'value': '0.246', 'groupId': 'OG004', 'lowerLimit': '0.212', 'upperLimit': '0.280'}, {'value': '-0.019', 'groupId': 'OG005', 'lowerLimit': '-0.063', 'upperLimit': '0.025'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.130', 'ciLowerLimit': '0.091', 'ciUpperLimit': '0.169', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.167', 'ciLowerLimit': '0.128', 'ciUpperLimit': '0.206', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.224', 'ciLowerLimit': '0.184', 'ciUpperLimit': '0.263', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.214', 'ciLowerLimit': '0.176', 'ciUpperLimit': '0.253', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.265', 'ciLowerLimit': '0.226', 'ciUpperLimit': '0.304', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.037', 'ciLowerLimit': '0.012', 'ciUpperLimit': '0.062', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.094', 'ciLowerLimit': '0.068', 'ciUpperLimit': '0.119', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.084', 'ciLowerLimit': '0.059', 'ciUpperLimit': '0.110', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.135', 'ciLowerLimit': '0.109', 'ciUpperLimit': '0.161', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.057', 'ciLowerLimit': '0.031', 'ciUpperLimit': '0.082', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.047', 'ciLowerLimit': '0.023', 'ciUpperLimit': '0.071', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.098', 'ciLowerLimit': '0.073', 'ciUpperLimit': '0.123', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.469', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.009', 'ciLowerLimit': '-0.035', 'ciUpperLimit': '0.016', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.041', 'ciLowerLimit': '0.015', 'ciUpperLimit': '0.068', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '0.025', 'ciUpperLimit': '0.076', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1: zero time to 6 hours post-dose', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.', 'unitOfMeasure': 'Litre/Hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant's adherence to the randomized treatment."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol Fumarate 6 μg', 'description': 'Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days'}, {'id': 'OG001', 'title': 'Formoterol Fumarate (FF) 12 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG002', 'title': 'Formoterol Fumarate (FF) 24 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG003', 'title': 'Perforomist 20 μg', 'description': 'Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days'}, {'id': 'OG004', 'title': 'Placebo (Lactose Monohydrate)', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.166', 'groupId': 'OG000', 'lowerLimit': '0.127', 'upperLimit': '0.205'}, {'value': '0.177', 'groupId': 'OG001', 'lowerLimit': '0.139', 'upperLimit': '0.215'}, {'value': '0.225', 'groupId': 'OG002', 'lowerLimit': '0.186', 'upperLimit': '0.265'}, {'value': '0.186', 'groupId': 'OG003', 'lowerLimit': '0.147', 'upperLimit': '0.225'}, {'value': '0.007', 'groupId': 'OG004', 'lowerLimit': '-0.050', 'upperLimit': '0.064'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.159', 'ciLowerLimit': '0.105', 'ciUpperLimit': '0.213', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.170', 'ciLowerLimit': '0.116', 'ciUpperLimit': '0.224', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.219', 'ciLowerLimit': '0.163', 'ciUpperLimit': '0.274', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.179', 'ciLowerLimit': '0.125', 'ciUpperLimit': '0.233', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.488', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.011', 'ciLowerLimit': '-0.020', 'ciUpperLimit': '0.042', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.060', 'ciLowerLimit': '0.027', 'ciUpperLimit': '0.092', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.206', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.020', 'ciLowerLimit': '-0.011', 'ciUpperLimit': '0.051', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.049', 'ciLowerLimit': '0.016', 'ciUpperLimit': '0.081', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.567', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.009', 'ciLowerLimit': '-0.022', 'ciUpperLimit': '0.041', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.017', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.039', 'ciLowerLimit': '-0.072', 'ciUpperLimit': '-0.007', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7: zero time to 6 hours post-dose', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation', 'unitOfMeasure': 'Litre/Hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant's adherence to the randomized treatment."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Formoterol Fumarate 6 μg', 'description': 'Randomized participants received 2 puffs of Formoterol Fumarate 6 μg oral inhalation powder using Pressair® dry powder inhaler (DPI) in the morning and evening for 7 (±1) days'}, {'id': 'OG001', 'title': 'Formoterol Fumarate (FF) 12 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 12 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG002', 'title': 'Formoterol Fumarate (FF) 24 μg', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}, {'id': 'OG003', 'title': 'Perforomist 20 μg', 'description': 'Randomized participants received 1 vial of Perforomist 20 μg oral nebulization solution via a jet nebulizer in the morning and evening for 7 (±1) days'}, {'id': 'OG004', 'title': 'Placebo (Lactose Monohydrate)', 'description': 'Randomized participants received two identical Pressair dry powder inhaler (DPI; FF 6/12/24 μg and placebo) and were instructed to take one puff from each of the two Pressair DPI in the morning and in the evening for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.077', 'groupId': 'OG000', 'lowerLimit': '0.044', 'upperLimit': '0.109'}, {'value': '0.067', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.098'}, {'value': '0.102', 'groupId': 'OG002', 'lowerLimit': '0.069', 'upperLimit': '0.135'}, {'value': '0.061', 'groupId': 'OG003', 'lowerLimit': '0.029', 'upperLimit': '0.092'}, {'value': '0.002', 'groupId': 'OG004', 'lowerLimit': '-0.059', 'upperLimit': '0.063'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.075', 'ciLowerLimit': '0.008', 'ciUpperLimit': '0.141', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.054', 'groupIds': ['OG001', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.065', 'ciLowerLimit': '-0.001', 'ciUpperLimit': '0.131', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG002', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '0.032', 'ciUpperLimit': '0.168', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.075', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.059', 'ciLowerLimit': '-0.006', 'ciUpperLimit': '0.123', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.010', 'ciLowerLimit': '-0.048', 'ciUpperLimit': '0.028', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.209', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.025', 'ciLowerLimit': '-0.014', 'ciUpperLimit': '0.065', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.403', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.016', 'ciLowerLimit': '-0.053', 'ciUpperLimit': '0.022', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.074', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.035', 'ciLowerLimit': '-0.003', 'ciUpperLimit': '0.074', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.750', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.006', 'ciLowerLimit': '-0.045', 'ciUpperLimit': '0.032', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.041', 'ciLowerLimit': '-0.080', 'ciUpperLimit': '-0.003', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and Day 7', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value.\n\nNote: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.', 'unitOfMeasure': 'Litre', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant's adherence to the randomized treatment."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Participants', 'description': 'All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair dry powder inhalers (DPI) and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.\n\nNote: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'Formoterol Fumarate (FF) 6 μg', 'comment': 'Participants had 1 puff each from 2 identical Pressair DPI (FF 6μg \\& placebo) in morning \\& evening', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}, {'type': 'Formoterol Fumarate (FF) 12 μg', 'comment': 'Participants had 1 puff each from 2 identical Pressair DPI (FF 12μg \\& placebo) in morning \\& evening', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'Formoterol Fumarate (FF) 24 μg', 'comment': 'Participants had 1 puff each from 2 identical Pressair DPI (FF 24μg \\& placebo) in morning \\& evening', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'Perforomist 20 μg', 'comment': 'Participants took 1 vial of Perforomist 20μg oral nebulization solution in morning \\& evening', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}]}, {'type': 'Perforomist 40 μg', 'comment': 'Participants took 1 dose of 2 vials of Perforomist 20μg oral nebulization solution on Day 1 morning', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'Placebo (Lactose Monohydrate)', 'comment': 'Participants had 1 puff from Pressair DPI (FF 6/12/24 μg matching placebo) in morning \\& evening', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'This study was carried on 132 participants with moderate to severe chronic obstructive pulmonary disease (COPD) \\& reversible airway disease in the United States of America (USA; 21 sites) \\& were randomized to one of treatment sequences (each with 5 periods of different treatment, separated by wash-out period of 7 (+/1) days after treatment period).', 'preAssignmentDetails': 'After signature of the informed consent, participants who were taking prohibited medication performed a wash-out period and were given Atrovent (2 puffs 4 times/day) before Screening and during the run-in period. All participants were provided with rescue drug (albuterol) and Atrovent to be taken during the wash-out between treatment periods.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Total', 'description': 'All patients were randomized in a treatment sequence containing 5 treatment periods. All patients received FF12 and Perforomist 20 mcg, 90% received FF6, FF24 and Perforomist 40 mcg, and only 30% received placebo. Treatment was double blind for FF in Pressair, and open label for Perforomist. If treatment was FF6, FF12, FF24 or placebo, patients received two identical Pressair DPI and were instructed to take 1 puff from each of the inhalers in the morning and in the evening for 7 days. If treatment was Perforomist 20 mcg, patients were instructed to take 1 vial in the morning and 1 vial in the evening for 7 days. Treatment with Perforomist 40 mcg was a single dose administration.\n\nNote: 132 participants were randomized. But, one participant was excluded from the ITT analysis set as the participant did not have a post-baseline forced expiratory volume in 1 second (FEV1) measurement.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '7.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<50 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '≥50 to <65 years', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "The ITT analysis set: Consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant's adherence to the randomized treatment."}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-11', 'studyFirstSubmitDate': '2016-06-07', 'resultsFirstSubmitDate': '2017-11-30', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-11', 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment', 'timeFrame': 'Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg).\n\nPre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them.\n\nNote: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment', 'timeFrame': 'Day 1: zero time to 6 hours post-dose', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.'}, {'measure': 'Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment', 'timeFrame': 'Day 7: zero time to 6 hours post-dose', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation'}, {'measure': 'Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment', 'timeFrame': 'At baseline and Day 7', 'description': 'To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value.\n\nNote: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perforomist', 'Pressair', 'COPD', 'Cigarette smoking', 'Formoterol fumarate', 'long-acting β2-adrenergic agonists (LABA)', 'long-acting muscarinic antagonists (LAMA)'], 'conditions': ['Chronic Obstructive Pulmonary Disease - COPD']}, 'descriptionModule': {'briefSummary': 'To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).', 'detailedDescription': 'This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover, placebo and active comparator (open-label) controlled, multicenter clinical trial to assess the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg BID and 40 μg single dose) administered as an inhalation solution via a standard jet nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation Solution). The drug product is an inhalation powder comprising of micronized aclidinium bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier, presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved under the trademarks of Genuair® and/or Pressair® in some territories.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male or non-pregnant, non-lactating female patients aged ≥40.\n* Patients with a diagnosis of COPD (GOLD guidelines, 2016) for a period of at least 6 months prior to Visit 1.\n* Patients with moderate to severe stable COPD: post-bronchodilator FEV1 ≥ 30% and \\<80% of the predicted normal and post-bronchodilator FEV1/FVC \\< 70% at Visit 1.\n* Patients with reversible airway obstruction defined as an increase in FEV1 of at least 12% and 200 mL over the baseline value after four inhalations of albuterol sulfate 108 µg via a pMDI at Visit 1.\n* Current or former-smokers, with a smoking history of ≥ 10 pack-years.\n* Patients able to perform acceptable and repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1.\n* Patients eligible and able to participate in the study and who had signed an Informed Consent Form prior to initiation of any study-related procedures.\n\nExclusion Criteria:\n\n* Patients with asthma.\n* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to Visit 1 or during the run-in period.\n* Patients hospitalized for a COPD exacerbation (an emergency room visit for longer than 24 hours is considered a hospitalization) within 3 months prior to Visit 1.\n* Clinically significant respiratory conditions other than COPD.\n* Patients who in the investigator's opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Visit 1.\n* Use of long-term oxygen therapy (≥ 15 hours/day).\n* Patients who do not maintain regular day/night, waking/sleeping cycles including night shift workers.\n* Clinically significant cardiovascular conditions.\n* Patients with uncontrolled Type I or Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled hypertension.\n* Patients with history of long QT syndrome or whose QTc (calculated according to Fridericia's Formula QTc=QT/RR1/3) \\> 470 ms as indicated in the centralized reading report assessed at Visit 1.\n* Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Visit 1 that might compromise patient safety.\n* Patients with a history of hypersensitivity reaction to an inhaled medication or any component thereof, including paradoxical bronchospasm.\n* Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic unstable prostate hypertrophy.\n* History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.\n* Patients with any other serious or uncontrolled physical or mental dysfunction.\n* Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment.\n* Patients unlikely to be cooperative or who cannot comply with the study procedures.\n* Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1.\n* Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication.\n* Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients.\n* Any other conditions that, in the investigator's opinion, might render the patient to be unsuitable for the study.\n* Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff), or patients employed by or relatives of the employees of the site or sponsor.\n* Previous randomization in the present study D6571C00002."}, 'identificationModule': {'nctId': 'NCT02796651', 'briefTitle': 'Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Incomplete Unbalanced, Crossover Study to Assess the Efficacy and Safety of Three Doses of Formoterol Fumarate in Pressair® Compared With Perforomist® Inhalation Solution (20 and 40 μg Open-label) in Moderate to Severe COPD Patients With Reversible Airway Disease.', 'orgStudyIdInfo': {'id': 'D6571C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formoterol 6 μg', 'description': 'Participants received formoterol fumarate 6 μg administered via Pressair twice daily (BID).', 'interventionNames': ['Drug: Formoterol fumarate (6 μg)']}, {'type': 'EXPERIMENTAL', 'label': 'Formoterol 12 μg', 'description': 'Participants received formoterol fumarate 12 μg administered via Pressair BID.', 'interventionNames': ['Drug: Formoterol fumarate (12 μg)']}, {'type': 'EXPERIMENTAL', 'label': 'Formoterol 24 μg', 'description': 'Participants received formoterol fumarate 24 μg administered via Pressair BID.', 'interventionNames': ['Drug: Formoterol fumarate (12 μg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo to formoterol fumarate administered via Pressair BID.', 'interventionNames': ['Drug: Placebo for formoterol fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Formoterol 20 μg', 'description': 'Participants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days.', 'interventionNames': ['Drug: Formoterol furmarate (20 μg)']}, {'type': 'EXPERIMENTAL', 'label': 'Formoterol 40 μg', 'description': 'Participants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration.', 'interventionNames': ['Drug: Formoterol fumarate (40 μg)']}], 'interventions': [{'name': 'Formoterol fumarate (6 μg)', 'type': 'DRUG', 'otherNames': ['Formoterol (Pressair®)'], 'description': 'Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)', 'armGroupLabels': ['Formoterol 6 μg']}, {'name': 'Formoterol furmarate (20 μg)', 'type': 'DRUG', 'otherNames': ['Perforomist® Inhalation Solution'], 'description': 'Oral Inhalation (via a standard jet nebulizer connected to an air compressor.', 'armGroupLabels': ['Formoterol 20 μg']}, {'name': 'Placebo for formoterol fumarate', 'type': 'DRUG', 'otherNames': ['Placebo (Pressair®)'], 'description': 'Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)', 'armGroupLabels': ['Placebo']}, {'name': 'Formoterol fumarate (12 μg)', 'type': 'DRUG', 'otherNames': ['Formoterol (Pressair®)'], 'description': 'Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)', 'armGroupLabels': ['Formoterol 12 μg', 'Formoterol 24 μg']}, {'name': 'Formoterol fumarate (40 μg)', 'type': 'DRUG', 'otherNames': ['Perforomist® Inhalation Solution'], 'description': 'Oral Inhalation (via a standard jet nebulizer connected to an air compressor.', 'armGroupLabels': ['Formoterol 40 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32825', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97202', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29640', 'city': 'Easley', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.82984, 'lon': -82.60152}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29372', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '78006', 'city': 'Boerne', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.79466, 'lon': -98.73197}}, {'zip': '76543', 'city': 'Killeen', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.11712, 'lon': -97.7278}}], 'overallOfficials': [{'name': 'Mark H. Gotfried, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '1112 East McDowell Road, Phoenix, AZ 85006, United States.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}