Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT01455194
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of High Dose Ciclesonide on Asthma Control
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': 'C120481', 'term': 'ciclesonide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical Study Information Center', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug.', 'description': 'Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Baseline Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.', 'otherNumAtRisk': 520, 'otherNumAffected': 64, 'seriousNumAtRisk': 520, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.', 'otherNumAtRisk': 119, 'otherNumAffected': 65, 'seriousNumAtRisk': 119, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.', 'otherNumAtRisk': 122, 'otherNumAffected': 65, 'seriousNumAtRisk': 122, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.', 'otherNumAtRisk': 126, 'otherNumAffected': 70, 'seriousNumAtRisk': 126, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Invertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cerebellar ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 520, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Asthma Control Questionnaire (ACQ) Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.24', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '2.19', 'spread': '0.032', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in ACQ Score to Tlast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.833', 'spread': '0.1028', 'groupId': 'OG000'}, {'value': '-0.799', 'spread': '0.1019', 'groupId': 'OG001'}, {'value': '-0.955', 'spread': '0.0969', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2988', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.122', 'ciLowerLimit': '-0.353', 'ciUpperLimit': '0.109', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1175', 'groupDescription': 'Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.034', 'ciLowerLimit': '-0.198', 'ciUpperLimit': '0.266', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1180', 'groupDescription': 'Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1835', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.156', 'ciLowerLimit': '-0.387', 'ciUpperLimit': '0.074', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1172', 'groupDescription': 'Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 52', 'description': 'The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Time Course of ACQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.100', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '4.40'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '3.90'}, {'value': '1.000', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '4.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 52 (Treatment period)', 'description': 'The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Weeks With Well-controlled Asthma Over the Course of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}, {'units': 'weeks', 'counts': [{'value': '5286', 'groupId': 'OG000'}, {'value': '5388', 'groupId': 'OG001'}, {'value': '5669', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1211', 'groupId': 'OG000'}, {'value': '1514', 'groupId': 'OG001'}, {'value': '1447', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8465', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hodges-Lehmann point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'ciLowerLimit': '-3.000', 'ciUpperLimit': '4.000', 'estimateComment': 'Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.000', 'ciLowerLimit': '-2.000', 'ciUpperLimit': '5.000', 'estimateComment': 'Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'weeks', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'weeks', 'denomUnitsSelected': 'weeks', 'populationDescription': 'The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'title': 'Well-controlled Asthma', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'ACQ Improvement', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4186', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Well-controlled Asthma', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1460', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Well-controlled Asthma', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6017', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Well-controlled Asthma', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3305', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'ACQ Improvement', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4860', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'ACQ Improvement', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8922', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'ACQ Improvement', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'title': 'Well-controlled Asthma', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'ACQ Improvement', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6062', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.042', 'ciLowerLimit': '0.890', 'ciUpperLimit': '1.221', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0806', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'Well-controlled Asthma', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4674', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.050', 'ciLowerLimit': '0.921', 'ciUpperLimit': '1.197', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0669', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ Improvement', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.201', 'ciLowerLimit': '0.878', 'ciUpperLimit': '1.642', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1597', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'Well-controlled Asthma', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.913', 'ciLowerLimit': '0.700', 'ciUpperLimit': '1.191', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1354', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ Improvement', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4893', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.898', 'ciLowerLimit': '0.661', 'ciUpperLimit': '1.219', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1560', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'Well-controlled Asthma', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2193', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.181', 'ciLowerLimit': '0.906', 'ciUpperLimit': '1.538', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1351', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ Improvement', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'title': 'ACQ cut-off at 0.5', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'ACQ cut-off at 1.0', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'ACQ cut-off at 1.25', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'ACQ cut-off at 1.5', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5397', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.058', 'ciLowerLimit': '0.884', 'ciUpperLimit': '1.266', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0917', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 0.5', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9458', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.005', 'ciLowerLimit': '0.870', 'ciUpperLimit': '1.161', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0738', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.0', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7213', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.026', 'ciLowerLimit': '0.893', 'ciUpperLimit': '1.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0708', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.25', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4807', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.050', 'ciLowerLimit': '0.917', 'ciUpperLimit': '1.202', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0692', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.5', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1150', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.326', 'ciLowerLimit': '0.934', 'ciUpperLimit': '1.884', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1791', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 0.5', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.074', 'ciLowerLimit': '0.805', 'ciUpperLimit': '1.431', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1467', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.0', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6853', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.059', 'ciLowerLimit': '0.803', 'ciUpperLimit': '1.397', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1415', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.25', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6995', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.055', 'ciLowerLimit': '0.804', 'ciUpperLimit': '1.385', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1388', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.5', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3080', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.837', 'ciLowerLimit': '0.595', 'ciUpperLimit': '1.178', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1744', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 0.5', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6645', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.939', 'ciLowerLimit': '0.705', 'ciUpperLimit': '1.250', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1461', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.0', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9564', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.992', 'ciLowerLimit': '0.753', 'ciUpperLimit': '1.308', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1408', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.25', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7367', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.047', 'ciLowerLimit': '0.800', 'ciUpperLimit': '1.371', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1375', 'estimateComment': 'A hazard ratio of \\>1 represented a benefit for the test treatment.', 'groupDescription': 'ACQ cut-off at 1.5', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Time to First Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2264', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.367', 'ciLowerLimit': '0.824', 'ciUpperLimit': '2.267', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2583', 'estimateComment': 'A hazard ratio of \\<1 represented a benefit for the test treatment.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.102', 'ciLowerLimit': '0.789', 'ciUpperLimit': '5.602', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5001', 'estimateComment': 'A hazard ratio of \\<1 represented a benefit for the test treatment.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7732', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.882', 'ciLowerLimit': '0.375', 'ciUpperLimit': '2.074', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4365', 'estimateComment': 'A hazard ratio of \\<1 represented a benefit for the test treatment.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Asthma Exacerbations Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2880', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2864', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly High Benefits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 up to Week 52', 'description': "The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '520', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG003', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP \\>170 millimeters of mercury (mm Hg) or \\<85 mm Hg, Diastolic BP \\>105 mm Hg, resting pulse rate: \\>120 bpm or \\<50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment \\>40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment \\>30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Markedly Abnormal Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'OG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Baseline Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.'}, {'id': 'FG001', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'FG002', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'FG003', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '122'}, {'groupId': 'FG003', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '92'}, {'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomisation Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Deterioration in asthma', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Discontinuation criterion fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 5 investigative sites in Argentina, Brazil, Germany, Israel and Russia from 10 November 2011 to 15 August 2014.', 'preAssignmentDetails': 'Participants with a historical diagnosis of persistent bronchial asthma for at least 6 months,treated with a stable inhaled corticosteroid (ICS)dose for at least 12 weeks were enrolled in a single-blind baseline period receiving 160 microgram(mcg)ciclesonide,then a double-blind treatment period in 1 of 3 treatment arms: ciclesonide 160,320,640 mcg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '367', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Period: Ciclesonide 160 mcg', 'description': 'Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'BG001', 'title': 'Treatment Period: Ciclesonide 320 mcg', 'description': 'Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'BG002', 'title': 'Treatment Period: Ciclesonide 640 mcg', 'description': 'Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '14.86', 'groupId': 'BG000'}, {'value': '44.7', 'spread': '15.60', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '16.22', 'groupId': 'BG002'}, {'value': '44.4', 'spread': '15.57', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '0.093', 'groupId': 'BG000'}, {'value': '1.66', 'spread': '0.101', 'groupId': 'BG001'}, {'value': '1.65', 'spread': '0.104', 'groupId': 'BG002'}, {'value': '1.65', 'spread': '0.099', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meter (m)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.59', 'spread': '16.371', 'groupId': 'BG000'}, {'value': '77.98', 'spread': '18.993', 'groupId': 'BG001'}, {'value': '73.72', 'spread': '14.660', 'groupId': 'BG002'}, {'value': '75.42', 'spread': '16.811', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.34', 'spread': '5.217', 'groupId': 'BG000'}, {'value': '28.42', 'spread': '6.346', 'groupId': 'BG001'}, {'value': '27.12', 'spread': '5.373', 'groupId': 'BG002'}, {'value': '27.62', 'spread': '5.681', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per meter square (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'History of exacerbations', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': '2-3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': '4+', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma.', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prestudy ICS dose', 'classes': [{'title': '<200(mcg/day) fluticasone propionate(FP)equivalent', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Low:>=200 mcg/day(=<)250 mcg/day FP equivalent', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}, {'title': 'Medium:>250 mcg/dayto=<500 mcg/day FP equivalent', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}]}, {'title': 'High:>500 mcg/dayto=<1000 mcg/day FP equivalent', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline asthma control questionnaire (ACQ)', 'classes': [{'categories': [{'measurements': [{'value': '2.24', 'spread': '0.304', 'groupId': 'BG000'}, {'value': '2.16', 'spread': '0.384', 'groupId': 'BG001'}, {'value': '2.20', 'spread': '0.361', 'groupId': 'BG002'}, {'value': '2.20', 'spread': '0.363', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'ACQ=5 questions about symptoms,1 question about beta 2-agonist use and 1 about lung function (FEV1% predicted).Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale.The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-forced expiratory volume in 1 second (FEV1)', 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'spread': '0.792', 'groupId': 'BG000'}, {'value': '2.35', 'spread': '0.798', 'groupId': 'BG001'}, {'value': '2.23', 'spread': '0.801', 'groupId': 'BG002'}, {'value': '2.26', 'spread': '0.797', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Pre-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration prior to salbutamol administration.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Post-FEV1', 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'spread': '0.915', 'groupId': 'BG000'}, {'value': '2.84', 'spread': '0.883', 'groupId': 'BG001'}, {'value': '2.76', 'spread': '0.906', 'groupId': 'BG002'}, {'value': '2.77', 'spread': '0.900', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Post-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration after salbutamol administration.', 'unitOfMeasure': 'L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1 reversibility', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '17.02', 'groupId': 'BG000'}, {'value': '23', 'spread': '17.10', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '20.78', 'groupId': 'BG002'}, {'value': '25.0', 'spread': '18.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Reversibility is assessed using FEV1 measurements. Percent reversibility is calculated as the difference between highest FEV1 after salbutamol and highest FEV 1 before salbutamol divided by highest FEV 1 before salbutamol. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.', 'unitOfMeasure': 'percent reversibility', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre FEV1 predicted', 'classes': [{'categories': [{'measurements': [{'value': '69.095', 'spread': '18.4683', 'groupId': 'BG000'}, {'value': '74.345', 'spread': '16.7285', 'groupId': 'BG001'}, {'value': '71.835', 'spread': '18.4365', 'groupId': 'BG002'}, {'value': '71.773', 'spread': '17.9737', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Pre-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration prior to salbutamol administration. It is converted to the percentage of predicted FEV1 based on age, gender, weight and race of participants. Generally, values between 80% to 120% are considered normal.', 'unitOfMeasure': 'percent of predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Post FEV1 predicted', 'classes': [{'categories': [{'measurements': [{'value': '84.893', 'spread': '19.3038', 'groupId': 'BG000'}, {'value': '90.168', 'spread': '17.7365', 'groupId': 'BG001'}, {'value': '88.505', 'spread': '17.7105', 'groupId': 'BG002'}, {'value': '87.875', 'spread': '18.3373', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Post-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration after salbutamol administration. It is converted to the percentage of predicted FEV1 based on age, gender, weight and race of participants. Generally, values between 80% to 120% are considered normal.', 'unitOfMeasure': 'percent of predicted', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The full analysis set (FAS) was defined as all randomized participants who took at least 1 dose of double-blind study medication.Baseline data was summarized only for those participants who entered treatment period which was the core period of the trial.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2011-10-17', 'resultsFirstSubmitDate': '2016-04-24', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-29', 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Control Questionnaire (ACQ) Score at Baseline', 'timeFrame': 'Baseline', 'description': 'The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.'}, {'measure': 'Change From Baseline in ACQ Score to Tlast', 'timeFrame': 'Week 52', 'description': 'The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.'}], 'secondaryOutcomes': [{'measure': 'Time Course of ACQ', 'timeFrame': 'Baseline, Week 52 (Treatment period)', 'description': 'The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.'}, {'measure': 'Number of Weeks With Well-controlled Asthma Over the Course of the Study', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.'}, {'measure': 'Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study', 'timeFrame': 'Week 52', 'description': 'Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.'}, {'measure': 'Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.'}, {'measure': 'Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>= 1.5 indicates uncontrolled asthma.'}, {'measure': 'Number of Participants Reporting Time to First Asthma Exacerbation', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication'}, {'measure': 'Number of Participants Reporting Asthma Exacerbations Rates', 'timeFrame': 'Baseline up to Week 52 (treatment period)', 'description': 'Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.'}, {'measure': 'Number of Participants With Markedly High Benefits', 'timeFrame': 'Week 1 up to Week 52', 'description': "The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =\\<0.75 indicate well-controlled asthma, scores between 0.76 and \\< 1.5 indicate partly controlled asthma, and a score \\>=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included."}, {'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.'}, {'measure': 'Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP \\>170 millimeters of mercury (mm Hg) or \\<85 mm Hg, Diastolic BP \\>105 mm Hg, resting pulse rate: \\>120 bpm or \\<50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment \\>40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment \\>30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.'}, {'measure': 'Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.'}, {'measure': 'Number of Participants With Markedly Abnormal Laboratory Values', 'timeFrame': 'Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)', 'description': 'The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ciclesonide', 'asthma'], 'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent was provided\n* History of persistent bronchial asthma for at least 6 months\n* Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks\n* Good inhalation technique\n* Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2\n\nExclusion Criteria:\n\n* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation\n* Concomitant severe diseases (e.g. malignant diseases during the past 5 years \\[other than basal or squamous cell carcinoma\\], hepatitis C, acquired immune deficiency syndrome \\[AIDS\\])\n* Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)\n* Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months'}, 'identificationModule': {'nctId': 'NCT01455194', 'acronym': 'CONTRAST', 'briefTitle': 'Effect of High Dose Ciclesonide on Asthma Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Control of Moderate or Severe Asthma With 160, 320 and 640 mcg Ciclesonide/Day. A One-year Randomised, Double-blind, Multicenter Trial.', 'orgStudyIdInfo': {'id': 'CL-9709-301-RD'}, 'secondaryIdInfos': [{'id': '2011-000683-99', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1133-6333', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'CL-9709-301-RDCTID', 'type': 'REGISTRY', 'domain': 'Israel'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CIC 160', 'description': 'Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg)', 'interventionNames': ['Drug: Ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CIC 320', 'description': 'Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg)', 'interventionNames': ['Drug: Ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CIC 640', 'description': 'Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg)', 'interventionNames': ['Drug: Ciclesonide']}], 'interventions': [{'name': 'Ciclesonide', 'type': 'DRUG', 'description': 'During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)', 'armGroupLabels': ['CIC 160', 'CIC 320', 'CIC 640']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Capital Federal, Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Rosario', 'country': 'Argentina', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Rosario-Santa Fe', 'country': 'Argentina'}, {'city': 'Salta', 'country': 'Argentina', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'Florianópolis', 'country': 'Brazil', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'Goiânia', 'country': 'Brazil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Rio de Janiero', 'country': 'Brazil'}, {'city': 'Santo André', 'country': 'Brazil', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Sorocaba', 'country': 'Brazil', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Landsberg', 'country': 'Germany', 'geoPoint': {'lat': 51.52698, 'lon': 12.16076}}, {'city': 'Rudersdorf', 'country': 'Germany', 'geoPoint': {'lat': 51.1, 'lon': 11.45}}, {'city': 'Schwetzingen', 'country': 'Germany', 'geoPoint': {'lat': 49.38217, 'lon': 8.5823}}, {'city': 'Beersheba', 'country': 'Israel', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Kfar Saba', 'country': 'Israel', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Petah Tikva', 'country': 'Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Rehovot', 'country': 'Israel', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'city': 'Tel Aviv', 'country': 'Israel', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Barnaul', 'country': 'Russia', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Novosibirsk', 'country': 'Russia', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Tomsk', 'country': 'Russia', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'AstraZeneca AstraZeneca', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}