Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 2:43 PM
Study NCT ID:
NCT01555151
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2012-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}, {'id': 'C000600413', 'term': 'QMF149'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1(862)778-8300', 'title': 'Clinical Disclosure Office', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening', 'otherNumAtRisk': 186, 'otherNumAffected': 13, 'seriousNumAtRisk': 186, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening', 'otherNumAtRisk': 180, 'otherNumAffected': 17, 'seriousNumAtRisk': 180, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening', 'otherNumAtRisk': 183, 'otherNumAffected': 15, 'seriousNumAtRisk': 183, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening', 'otherNumAtRisk': 186, 'otherNumAffected': 8, 'seriousNumAtRisk': 186, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 735, 'otherNumAffected': 53, 'seriousNumAtRisk': 735, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 735, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood cortisol decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 735, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 735, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 735, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 735, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 735, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'categories': [{'measurements': [{'value': '2.139', 'spread': '0.0281', 'groupId': 'OG000'}, {'value': '2.071', 'spread': '0.0283', 'groupId': 'OG001'}, {'value': '2.187', 'spread': '0.0281', 'groupId': 'OG002'}, {'value': '2.162', 'spread': '0.0279', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 29', 'description': 'Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Day 8 (n=178,173,181,181)', 'categories': [{'measurements': [{'value': '2.069', 'spread': '0.0252', 'groupId': 'OG000'}, {'value': '2.057', 'spread': '0.0253', 'groupId': 'OG001'}, {'value': '2.113', 'spread': '0.0251', 'groupId': 'OG002'}, {'value': '2.111', 'spread': '0.0250', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 (n=179,171,177,178)', 'categories': [{'measurements': [{'value': '2.095', 'spread': '0.0254', 'groupId': 'OG000'}, {'value': '2.048', 'spread': '0.0258', 'groupId': 'OG001'}, {'value': '2.134', 'spread': '0.0257', 'groupId': 'OG002'}, {'value': '2.135', 'spread': '0.0255', 'groupId': 'OG003'}]}]}, {'title': 'Day 22 (n=174,170,177,177)', 'categories': [{'measurements': [{'value': '2.126', 'spread': '0.0284', 'groupId': 'OG000'}, {'value': '2.071', 'spread': '0.0286', 'groupId': 'OG001'}, {'value': '2.175', 'spread': '0.0283', 'groupId': 'OG002'}, {'value': '2.146', 'spread': '0.0282', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 8, 15 and 22', 'description': 'Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Forced Vital Capacity (FVC) at All Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Day 1/30 min post-dose (n=172,172,175,173)', 'categories': [{'measurements': [{'value': '2.892', 'spread': '0.0208', 'groupId': 'OG000'}, {'value': '2.893', 'spread': '0.0207', 'groupId': 'OG001'}, {'value': '2.861', 'spread': '0.0209', 'groupId': 'OG002'}, {'value': '2.897', 'spread': '0.0208', 'groupId': 'OG003'}]}]}, {'title': 'Day 1/1 hr post-dose (n=178,169,174,175)', 'categories': [{'measurements': [{'value': '2.930', 'spread': '0.0234', 'groupId': 'OG000'}, {'value': '2.913', 'spread': '0.0238', 'groupId': 'OG001'}, {'value': '2.943', 'spread': '0.0238', 'groupId': 'OG002'}, {'value': '2.946', 'spread': '0.0235', 'groupId': 'OG003'}]}]}, {'title': 'Day 8/50 min pre-dose (n=174,171,179,174)', 'categories': [{'measurements': [{'value': '3.111', 'spread': '0.0325', 'groupId': 'OG000'}, {'value': '3.096', 'spread': '0.0325', 'groupId': 'OG001'}, {'value': '3.134', 'spread': '0.0321', 'groupId': 'OG002'}, {'value': '3.139', 'spread': '0.0324', 'groupId': 'OG003'}]}]}, {'title': 'Day 8/15 min pre-dose (n=176,172,179,174)', 'categories': [{'measurements': [{'value': '3.099', 'spread': '0.0324', 'groupId': 'OG000'}, {'value': '3.074', 'spread': '0.0324', 'groupId': 'OG001'}, {'value': '3.121', 'spread': '0.0321', 'groupId': 'OG002'}, {'value': '3.125', 'spread': '0.0323', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 /50 min pre-dose (n=175,169,170,169)', 'categories': [{'measurements': [{'value': '3.134', 'spread': '0.0342', 'groupId': 'OG000'}, {'value': '3.090', 'spread': '0.0347', 'groupId': 'OG001'}, {'value': '3.168', 'spread': '0.0348', 'groupId': 'OG002'}, {'value': '3.155', 'spread': '0.0348', 'groupId': 'OG003'}]}]}, {'title': 'Day 15/15 min pre-dose (n=176,168,176,167)', 'categories': [{'measurements': [{'value': '3.109', 'spread': '0.0343', 'groupId': 'OG000'}, {'value': '3.076', 'spread': '0.0348', 'groupId': 'OG001'}, {'value': '3.137', 'spread': '0.0345', 'groupId': 'OG002'}, {'value': '3.127', 'spread': '0.0348', 'groupId': 'OG003'}]}]}, {'title': 'Day 22/50 min pre-dose (n=172,167,174,169)', 'categories': [{'measurements': [{'value': '3.136', 'spread': '0.0356', 'groupId': 'OG000'}, {'value': '3.091', 'spread': '0.0359', 'groupId': 'OG001'}, {'value': '3.203', 'spread': '0.0355', 'groupId': 'OG002'}, {'value': '3.152', 'spread': '0.0357', 'groupId': 'OG003'}]}]}, {'title': 'Day 22/15 min pre-dose (n=169,170,174,172)', 'categories': [{'measurements': [{'value': '3.134', 'spread': '0.0365', 'groupId': 'OG000'}, {'value': '3.096', 'spread': '0.0363', 'groupId': 'OG001'}, {'value': '3.198', 'spread': '0.0362', 'groupId': 'OG002'}, {'value': '3.157', 'spread': '0.0361', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/50 min pre-dose (n=172,168,176,172)', 'categories': [{'measurements': [{'value': '3.146', 'spread': '0.0342', 'groupId': 'OG000'}, {'value': '3.115', 'spread': '0.0345', 'groupId': 'OG001'}, {'value': '3.184', 'spread': '0.0340', 'groupId': 'OG002'}, {'value': '3.180', 'spread': '0.0342', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/15 min pre-dose (n=170,165,174, 170)', 'categories': [{'measurements': [{'value': '3.135', 'spread': '0.0345', 'groupId': 'OG000'}, {'value': '3.095', 'spread': '0.0348', 'groupId': 'OG001'}, {'value': '3.153', 'spread': '0.0343', 'groupId': 'OG002'}, {'value': '3.161', 'spread': '0.0344', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/30 min post-dose (n=175,166,174,170)', 'categories': [{'measurements': [{'value': '3.132', 'spread': '0.0341', 'groupId': 'OG000'}, {'value': '3.092', 'spread': '0.0346', 'groupId': 'OG001'}, {'value': '3.151', 'spread': '0.0343', 'groupId': 'OG002'}, {'value': '3.184', 'spread': '0.0343', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/30 min post-dose (n=173,167,172,172)', 'categories': [{'measurements': [{'value': '3.140', 'spread': '0.0351', 'groupId': 'OG000'}, {'value': '3.084', 'spread': '0.0353', 'groupId': 'OG001'}, {'value': '3.158', 'spread': '0.0353', 'groupId': 'OG002'}, {'value': '3.161', 'spread': '0.0350', 'groupId': 'OG003'}]}]}, {'title': 'Day 29/23hr 10 min post-dose (n=173,162,172,168)', 'categories': [{'measurements': [{'value': '3.160', 'spread': '0.0342', 'groupId': 'OG000'}, {'value': '3.113', 'spread': '0.0348', 'groupId': 'OG001'}, {'value': '3.216', 'spread': '0.0343', 'groupId': 'OG002'}, {'value': '3.194', 'spread': '0.0344', 'groupId': 'OG003'}]}]}, {'title': 'Day 29/23hr 45 min post-dose (n=172,161, 175,170)', 'categories': [{'measurements': [{'value': '3.165', 'spread': '0.0355', 'groupId': 'OG000'}, {'value': '3.090', 'spread': '0.0363', 'groupId': 'OG001'}, {'value': '3.192', 'spread': '0.0353', 'groupId': 'OG002'}, {'value': '3.158', 'spread': '0.0355', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1, 8, 15, 22, 28 and 29 at all time points', 'description': 'Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Day 1/30 min post-dose (n=172,172,175,172)', 'categories': [{'measurements': [{'value': '1.308', 'spread': '0.0181', 'groupId': 'OG000'}, {'value': '1.300', 'spread': '0.0182', 'groupId': 'OG001'}, {'value': '1.309', 'spread': '0.0182', 'groupId': 'OG002'}, {'value': '1.308', 'spread': '0.0182', 'groupId': 'OG003'}]}]}, {'title': 'Day 1/1 hr post-dose (n=178,169,174,174)', 'categories': [{'measurements': [{'value': '1.337', 'spread': '0.0197', 'groupId': 'OG000'}, {'value': '1.327', 'spread': '0.0201', 'groupId': 'OG001'}, {'value': '1.316', 'spread': '0.0201', 'groupId': 'OG002'}, {'value': '1.345', 'spread': '0.0199', 'groupId': 'OG003'}]}]}, {'title': 'Day 8/50 min pre-dose (n=173,171,179,174)', 'categories': [{'measurements': [{'value': '1.457', 'spread': '0.0323', 'groupId': 'OG000'}, {'value': '1.449', 'spread': '0.0322', 'groupId': 'OG001'}, {'value': '1.519', 'spread': '0.0317', 'groupId': 'OG002'}, {'value': '1.525', 'spread': '0.0321', 'groupId': 'OG003'}]}]}, {'title': 'Day 8/15 min pre-dose (n=175,172,179,173)', 'categories': [{'measurements': [{'value': '1.458', 'spread': '0.0329', 'groupId': 'OG000'}, {'value': '1.466', 'spread': '0.0328', 'groupId': 'OG001'}, {'value': '1.542', 'spread': '0.0325', 'groupId': 'OG002'}, {'value': '1.566', 'spread': '0.0328', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 /50 min pre-dose (n=175,169,170,169)', 'categories': [{'measurements': [{'value': '1.509', 'spread': '0.0317', 'groupId': 'OG000'}, {'value': '1.430', 'spread': '0.0321', 'groupId': 'OG001'}, {'value': '1.514', 'spread': '0.0320', 'groupId': 'OG002'}, {'value': '1.544', 'spread': '0.0321', 'groupId': 'OG003'}]}]}, {'title': 'Day 15/15 min pre-dose (n=175,168,176,167)', 'categories': [{'measurements': [{'value': '1.494', 'spread': '0.0322', 'groupId': 'OG000'}, {'value': '1.414', 'spread': '0.0326', 'groupId': 'OG001'}, {'value': '1.520', 'spread': '0.0321', 'groupId': 'OG002'}, {'value': '1.561', 'spread': '0.0327', 'groupId': 'OG003'}]}]}, {'title': 'Day 22/50 min pre-dose (n=171,167,174,169)', 'categories': [{'measurements': [{'value': '1.511', 'spread': '0.0350', 'groupId': 'OG000'}, {'value': '1.440', 'spread': '0.0353', 'groupId': 'OG001'}, {'value': '1.565', 'spread': '0.0348', 'groupId': 'OG002'}, {'value': '1.555', 'spread': '0.0351', 'groupId': 'OG003'}]}]}, {'title': 'Day 22/15 min pre-dose (n=168,170,174,172)', 'categories': [{'measurements': [{'value': '1.540', 'spread': '0.0365', 'groupId': 'OG000'}, {'value': '1.476', 'spread': '0.0362', 'groupId': 'OG001'}, {'value': '1.600', 'spread': '0.0361', 'groupId': 'OG002'}, {'value': '1.591', 'spread': '0.0361', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/50 min pre-dose (n=171,168,176,172)', 'categories': [{'measurements': [{'value': '1.504', 'spread': '0.0353', 'groupId': 'OG000'}, {'value': '1.458', 'spread': '0.0354', 'groupId': 'OG001'}, {'value': '1.581', 'spread': '0.0350', 'groupId': 'OG002'}, {'value': '1.598', 'spread': '0.0351', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/15 min pre-dose (n=169,165,174, 170)', 'categories': [{'measurements': [{'value': '1.529', 'spread': '0.0357', 'groupId': 'OG000'}, {'value': '1.481', 'spread': '0.0359', 'groupId': 'OG001'}, {'value': '1.574', 'spread': '0.0354', 'groupId': 'OG002'}, {'value': '1.584', 'spread': '0.0355', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/30 min post-dose (n=175,166,174,170)', 'categories': [{'measurements': [{'value': '1.558', 'spread': '0.0362', 'groupId': 'OG000'}, {'value': '1.457', 'spread': '0.0368', 'groupId': 'OG001'}, {'value': '1.557', 'spread': '0.0364', 'groupId': 'OG002'}, {'value': '1.615', 'spread': '0.0364', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/30 min post-dose (n=172,167,172,172)', 'categories': [{'measurements': [{'value': '1.566', 'spread': '0.0367', 'groupId': 'OG000'}, {'value': '1.460', 'spread': '0.0369', 'groupId': 'OG001'}, {'value': '1.577', 'spread': '0.0368', 'groupId': 'OG002'}, {'value': '1.593', 'spread': '0.0365', 'groupId': 'OG003'}]}]}, {'title': 'Day 29/23hr 10 min post-dose (n=172,162,172,168)', 'categories': [{'measurements': [{'value': '1.537', 'spread': '0.0369', 'groupId': 'OG000'}, {'value': '1.451', 'spread': '0.0376', 'groupId': 'OG001'}, {'value': '1.604', 'spread': '0.0369', 'groupId': 'OG002'}, {'value': '1.584', 'spread': '0.0371', 'groupId': 'OG003'}]}]}, {'title': 'Day 29/23hr 45 min post-dose (n=171,161, 175,170)', 'categories': [{'measurements': [{'value': '1.550', 'spread': '0.0370', 'groupId': 'OG000'}, {'value': '1.438', 'spread': '0.0378', 'groupId': 'OG001'}, {'value': '1.576', 'spread': '0.0366', 'groupId': 'OG002'}, {'value': '1.571', 'spread': '0.0369', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1, 8, 15, 22, 28 and 29 at all time points', 'description': 'The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.', 'unitOfMeasure': 'Liters per second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Day 1/30 min post-dose (n=172,172,175,173)', 'categories': [{'measurements': [{'value': '65.043', 'spread': '0.2548', 'groupId': 'OG000'}, {'value': '64.898', 'spread': '0.2556', 'groupId': 'OG001'}, {'value': '65.184', 'spread': '0.2559', 'groupId': 'OG002'}, {'value': '64.898', 'spread': '0.2554', 'groupId': 'OG003'}]}]}, {'title': 'Day 1/1 hr post-dose (n=178,169,174,175)', 'categories': [{'measurements': [{'value': '65.177', 'spread': '0.2833', 'groupId': 'OG000'}, {'value': '64.833', 'spread': '0.2890', 'groupId': 'OG001'}, {'value': '65.005', 'spread': '0.2885', 'groupId': 'OG002'}, {'value': '65.072', 'spread': '0.2845', 'groupId': 'OG003'}]}]}, {'title': 'Day 8/50 min pre-dose (n=174,171,179,175)', 'categories': [{'measurements': [{'value': '66.566', 'spread': '0.4281', 'groupId': 'OG000'}, {'value': '66.301', 'spread': '0.4286', 'groupId': 'OG001'}, {'value': '67.344', 'spread': '0.4222', 'groupId': 'OG002'}, {'value': '66.568', 'spread': '0.4264', 'groupId': 'OG003'}]}]}, {'title': 'Day 8/15 min pre-dose (n=176,172,179,174)', 'categories': [{'measurements': [{'value': '66.595', 'spread': '0.4259', 'groupId': 'OG000'}, {'value': '66.790', 'spread': '0.4262', 'groupId': 'OG001'}, {'value': '67.778', 'spread': '0.4224', 'groupId': 'OG002'}, {'value': '67.156', 'spread': '0.4252', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 /50 min pre-dose (n=176,169,170,169)', 'categories': [{'measurements': [{'value': '67.007', 'spread': '0.4329', 'groupId': 'OG000'}, {'value': '66.122', 'spread': '0.4398', 'groupId': 'OG001'}, {'value': '67.487', 'spread': '0.4395', 'groupId': 'OG002'}, {'value': '67.139', 'spread': '0.4407', 'groupId': 'OG003'}]}]}, {'title': 'Day 15/15 min pre-dose (n=176,168,176,167)', 'categories': [{'measurements': [{'value': '66.878', 'spread': '0.4370', 'groupId': 'OG000'}, {'value': '66.006', 'spread': '0.4443', 'groupId': 'OG001'}, {'value': '67.607', 'spread': '0.4384', 'groupId': 'OG002'}, {'value': '67.514', 'spread': '0.4456', 'groupId': 'OG003'}]}]}, {'title': 'Day 22/50 min pre-dose (n=172,167,174,169)', 'categories': [{'measurements': [{'value': '67.081', 'spread': '0.4594', 'groupId': 'OG000'}, {'value': '66.567', 'spread': '0.4643', 'groupId': 'OG001'}, {'value': '67.831', 'spread': '0.4584', 'groupId': 'OG002'}, {'value': '67.742', 'spread': '0.4615', 'groupId': 'OG003'}]}]}, {'title': 'Day 22/15 min pre-dose (n=169,170,174,172)', 'categories': [{'measurements': [{'value': '67.403', 'spread': '0.4657', 'groupId': 'OG000'}, {'value': '66.885', 'spread': '0.4629', 'groupId': 'OG001'}, {'value': '68.143', 'spread': '0.4622', 'groupId': 'OG002'}, {'value': '67.895', 'spread': '0.4612', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/50 min pre-dose (n=172,168,176,172)', 'categories': [{'measurements': [{'value': '67.128', 'spread': '0.4584', 'groupId': 'OG000'}, {'value': '66.835', 'spread': '0.4615', 'groupId': 'OG001'}, {'value': '68.124', 'spread': '0.4567', 'groupId': 'OG002'}, {'value': '67.810', 'spread': '0.4578', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/15 min pre-dose (n=170,165,174, 170)', 'categories': [{'measurements': [{'value': '67.503', 'spread': '0.4813', 'groupId': 'OG000'}, {'value': '67.296', 'spread': '0.4854', 'groupId': 'OG001'}, {'value': '68.255', 'spread': '0.4796', 'groupId': 'OG002'}, {'value': '67.878', 'spread': '0.4804', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/30 min post-dose (n=175,166,174,170)', 'categories': [{'measurements': [{'value': '67.700', 'spread': '0.4723', 'groupId': 'OG000'}, {'value': '67.013', 'spread': '0.4796', 'groupId': 'OG001'}, {'value': '68.031', 'spread': '0.4755', 'groupId': 'OG002'}, {'value': '68.126', 'spread': '0.4755', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/30 min post-dose (n=173,167,172,172)', 'categories': [{'measurements': [{'value': '67.945', 'spread': '0.4703', 'groupId': 'OG000'}, {'value': '66.832', 'spread': '0.4741', 'groupId': 'OG001'}, {'value': '68.243', 'spread': '0.4736', 'groupId': 'OG002'}, {'value': '68.057', 'spread': '0.4698', 'groupId': 'OG003'}]}]}, {'title': 'Day 29/23hr 10 min post-dose (n=173,162,172,168)', 'categories': [{'measurements': [{'value': '67.427', 'spread': '0.4639', 'groupId': 'OG000'}, {'value': '66.711', 'spread': '0.4736', 'groupId': 'OG001'}, {'value': '68.265', 'spread': '0.4654', 'groupId': 'OG002'}, {'value': '67.592', 'spread': '0.4676', 'groupId': 'OG003'}]}]}, {'title': 'Day 29/23hr 45 min post-dose (n=172,161, 175,170)', 'categories': [{'measurements': [{'value': '67.630', 'spread': '0.4694', 'groupId': 'OG000'}, {'value': '66.541', 'spread': '0.4806', 'groupId': 'OG001'}, {'value': '67.961', 'spread': '0.4667', 'groupId': 'OG002'}, {'value': '67.831', 'spread': '0.4692', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1, 8, 15, 22, 28 and 29 at all time points', 'description': 'Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Morning 4 wks-baseline (n=177,171, 175, 182)', 'categories': [{'measurements': [{'value': '-4.952', 'spread': '4.1929', 'groupId': 'OG000'}, {'value': '3.955', 'spread': '4.2616', 'groupId': 'OG001'}, {'value': '2.785', 'spread': '4.2349', 'groupId': 'OG002'}, {'value': '1.606', 'spread': '4.1464', 'groupId': 'OG003'}]}]}, {'title': 'Evening 4 wks-baseline (n=176, 172, 174, 179)', 'categories': [{'measurements': [{'value': '1.354', 'spread': '3.9003', 'groupId': 'OG000'}, {'value': '0.293', 'spread': '3.9477', 'groupId': 'OG001'}, {'value': '-0.644', 'spread': '3.9427', 'groupId': 'OG002'}, {'value': '6.287', 'spread': '3.8826', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 4', 'description': 'Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.', 'unitOfMeasure': 'Liters per min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Day 8-baseline (n=179,176,182,182)', 'categories': [{'measurements': [{'value': '-0.662', 'spread': '0.0543', 'groupId': 'OG000'}, {'value': '-0.730', 'spread': '0.0546', 'groupId': 'OG001'}, {'value': '-0.908', 'spread': '0.0540', 'groupId': 'OG002'}, {'value': '-0.890', 'spread': '0.0538', 'groupId': 'OG003'}]}]}, {'title': 'Day 15-baseline(n=180,174,179,178)', 'categories': [{'measurements': [{'value': '-0.899', 'spread': '0.0590', 'groupId': 'OG000'}, {'value': '-0.908', 'spread': '0.0599', 'groupId': 'OG001'}, {'value': '-1.117', 'spread': '0.0595', 'groupId': 'OG002'}, {'value': '-0.973', 'spread': '0.0593', 'groupId': 'OG003'}]}]}, {'title': 'Day 22-baseline (n=178,173,178,177)', 'categories': [{'measurements': [{'value': '-0.994', 'spread': '0.0620', 'groupId': 'OG000'}, {'value': '-0.982', 'spread': '0.0628', 'groupId': 'OG001'}, {'value': '-1.262', 'spread': '0.0622', 'groupId': 'OG002'}, {'value': '-1.097', 'spread': '0.0622', 'groupId': 'OG003'}]}]}, {'title': 'Day 29-baseline (n=179,176,181,182)', 'categories': [{'measurements': [{'value': '-1.079', 'spread': '0.0630', 'groupId': 'OG000'}, {'value': '-1.109', 'spread': '0.602', 'groupId': 'OG001'}, {'value': '-1.329', 'spread': '0.0632', 'groupId': 'OG002'}, {'value': '-1.162', 'spread': '0.0625', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, days 8,15,22 and 29', 'description': 'Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.456', 'spread': '0.0972', 'groupId': 'OG000'}, {'value': '-0.391', 'spread': '0.0985', 'groupId': 'OG001'}, {'value': '-0.600', 'spread': '0.0981', 'groupId': 'OG002'}, {'value': '-0.677', 'spread': '0.0963', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.', 'unitOfMeasure': 'number of puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'categories': [{'measurements': [{'value': '74.148', 'spread': '2.2576', 'groupId': 'OG000'}, {'value': '75.236', 'spread': '2.3291', 'groupId': 'OG001'}, {'value': '75.157', 'spread': '2.3044', 'groupId': 'OG002'}, {'value': '80.578', 'spread': '2.3476', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 weeks', 'description': 'Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.\n\nA day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.\n\nThe total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.', 'unitOfMeasure': 'percentage days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Day 15 (n= 142, 139, 139, 149)', 'categories': [{'measurements': [{'value': '25.286', 'spread': '1.2983', 'groupId': 'OG000'}, {'value': '26.762', 'spread': '1.3201', 'groupId': 'OG001'}, {'value': '19.098', 'spread': '1.3246', 'groupId': 'OG002'}, {'value': '21.017', 'spread': '1.2911', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 (n=141, 143, 145, 150)', 'categories': [{'measurements': [{'value': '23.777', 'spread': '1.3078', 'groupId': 'OG000'}, {'value': '27.055', 'spread': '1.3035', 'groupId': 'OG001'}, {'value': '18.468', 'spread': '1.2952', 'groupId': 'OG002'}, {'value': '19.981', 'spread': '1.2803', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 15 and 29', 'description': 'FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.'}, {'type': 'SECONDARY', 'title': 'Plasma Cortisol Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'OG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'OG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'OG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'classes': [{'title': 'Baseline (n= 183, 178, 179, 181)', 'categories': [{'measurements': [{'value': '150.040', 'spread': '80.3928', 'groupId': 'OG000'}, {'value': '143.132', 'spread': '88.4206', 'groupId': 'OG001'}, {'value': '143.791', 'spread': '85.8696', 'groupId': 'OG002'}, {'value': '150.108', 'spread': '88.6815', 'groupId': 'OG003'}]}]}, {'title': 'Day 1/1 Hr (n=179, 177,174, 176)', 'categories': [{'measurements': [{'value': '118.130', 'spread': '92.7539', 'groupId': 'OG000'}, {'value': '106.965', 'spread': '81.5160', 'groupId': 'OG001'}, {'value': '107.526', 'spread': '74.3770', 'groupId': 'OG002'}, {'value': '115.489', 'spread': '79.3869', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/-25 Mins (n= 172, 169, 174, 172)', 'categories': [{'measurements': [{'value': '140.760', 'spread': '73.3567', 'groupId': 'OG000'}, {'value': '140.604', 'spread': '72.8885', 'groupId': 'OG001'}, {'value': '143.555', 'spread': '82.4961', 'groupId': 'OG002'}, {'value': '145.484', 'spread': '92.2940', 'groupId': 'OG003'}]}]}, {'title': 'Day 28/1 Hr (n= 172, 168, 174, 170)', 'categories': [{'measurements': [{'value': '105.399', 'spread': '68.9416', 'groupId': 'OG000'}, {'value': '107.931', 'spread': '70.7374', 'groupId': 'OG001'}, {'value': '105.468', 'spread': '57.9029', 'groupId': 'OG002'}, {'value': '110.477', 'spread': '77.2220', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, days 1 and 28', 'description': 'Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set includes all subjects who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'FG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'FG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'FG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '181'}, {'groupId': 'FG002', 'numSubjects': '184'}, {'groupId': 'FG003', 'numSubjects': '186'}]}, {'type': 'Safety Set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '183'}, {'groupId': 'FG003', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '173'}, {'groupId': 'FG002', 'numSubjects': '178'}, {'groupId': 'FG003', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}, {'value': '739', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Mometasone Furoate 80 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening'}, {'id': 'BG001', 'title': 'Mometasone Furoate 200 ug Daily Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening'}, {'id': 'BG002', 'title': 'Mometasone Furoate 320 ug Daily Via the Concept1 Device', 'description': 'Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening'}, {'id': 'BG003', 'title': 'Mometasone Furoate 800 ug Via the Twisthaler® Device', 'description': 'Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '16.33', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '15.56', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '16.18', 'groupId': 'BG002'}, {'value': '45.5', 'spread': '16.57', 'groupId': 'BG003'}, {'value': '45.4', 'spread': '16.15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '402', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '337', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 739}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2012-03-13', 'resultsFirstSubmitDate': '2014-07-06', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2015-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-06', 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 29', 'description': 'Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.'}], 'secondaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment', 'timeFrame': 'Days 8, 15 and 22', 'description': 'Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.'}, {'measure': 'Forced Vital Capacity (FVC) at All Time Points', 'timeFrame': 'Days 1, 8, 15, 22, 28 and 29 at all time points', 'description': 'Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.'}, {'measure': 'Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points', 'timeFrame': 'Days 1, 8, 15, 22, 28 and 29 at all time points', 'description': 'The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.'}, {'measure': 'Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points', 'timeFrame': 'Days 1, 8, 15, 22, 28 and 29 at all time points', 'description': 'Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.'}, {'measure': 'Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment', 'timeFrame': 'Baseline and week 4', 'description': 'Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.'}, {'measure': 'Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit', 'timeFrame': 'Baseline, days 8,15,22 and 29', 'description': 'Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).'}, {'measure': 'Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.'}, {'measure': 'Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment', 'timeFrame': '4 weeks', 'description': 'Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.\n\nA day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.\n\nThe total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.'}, {'measure': 'Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'Days 15 and 29', 'description': 'FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.'}, {'measure': 'Plasma Cortisol Concentrations', 'timeFrame': 'Baseline, days 1 and 28', 'description': 'Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females who were ≥ 12 years old at the time informed consent was obtained\n* Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria\n* Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).\n* Patients whose level of asthma control according to GINA 2010 guideline was "Partly Controlled" or "Uncontrolled" at screening (Visit 2).\n* Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2).\n* Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5.\n* Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit 5.\n\nKey exclusion criteria included:\n\n* Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated 2010.\n* Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.\n* Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.\n* Patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator.\n* Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).\n* Patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).\n* Patients who have ever required intubation for a severe asthma attack/exacerbation.\n* Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1, or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01555151', 'briefTitle': 'Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma', 'orgStudyIdInfo': {'id': 'CQMF149E2201'}, 'secondaryIdInfos': [{'id': '2011-005100-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mometasone furoate 80 μg', 'description': 'Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.', 'interventionNames': ['Drug: Mometasone furoate', 'Device: Concept 1']}, {'type': 'EXPERIMENTAL', 'label': 'Mometasone furoate 200 µg', 'description': 'Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.', 'interventionNames': ['Drug: Mometasone furoate', 'Device: Twisthaler']}, {'type': 'EXPERIMENTAL', 'label': 'Mometasone furoate 320 µg', 'description': 'Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.', 'interventionNames': ['Drug: Mometasone furoate', 'Device: Concept 1']}, {'type': 'EXPERIMENTAL', 'label': 'Mometasone furoate 800 µg', 'description': 'Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.', 'interventionNames': ['Drug: Mometasone furoate', 'Device: Twisthaler']}], 'interventions': [{'name': 'Mometasone furoate', 'type': 'DRUG', 'otherNames': ['QMF149'], 'description': 'Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device', 'armGroupLabels': ['Mometasone furoate 200 µg', 'Mometasone furoate 320 µg', 'Mometasone furoate 80 μg', 'Mometasone furoate 800 µg']}, {'name': 'Concept 1', 'type': 'DEVICE', 'description': 'A single dose dry powder inhaler (SDDPI)', 'armGroupLabels': ['Mometasone furoate 320 µg', 'Mometasone furoate 80 μg']}, {'name': 'Twisthaler', 'type': 'DEVICE', 'description': 'A single dose dry powder inhaler (SDDPI)', 'armGroupLabels': ['Mometasone furoate 200 µg', 'Mometasone furoate 800 µg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8500', 'city': 'Kortrijk', 'state': 'Belgium', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '4000', 'city': 'Liège', 'state': 'Belgium', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'L2G 1J4', 'city': 'Niagara Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.10012, 'lon': -79.06627}}, {'zip': 'N8X 5A6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, 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