Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00163293
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
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': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.', 'eventGroups': [{'id': 'EG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.', 'otherNumAtRisk': 79, 'otherNumAffected': 56, 'seriousNumAtRisk': 79, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.', 'otherNumAtRisk': 76, 'otherNumAffected': 55, 'seriousNumAtRisk': 76, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.', 'otherNumAtRisk': 84, 'otherNumAffected': 56, 'seriousNumAtRisk': 84, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 30, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 28, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 35, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Headache', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Asthma', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 60, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 64, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 82, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 9.1'}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myringoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '225.1', 'spread': '14.73', 'groupId': 'OG000'}, {'value': '249.5', 'spread': '14.79', 'groupId': 'OG001'}, {'value': '227.2', 'spread': '15.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6625', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7303', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months', 'description': 'Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat (ITT) analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.'}, {'type': 'PRIMARY', 'title': 'Exacerbations (Post-hoc Analysis of Annual Rates)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9343', 'spread': '0.2909', 'groupId': 'OG000'}, {'value': '0.8794', 'spread': '0.2747', 'groupId': 'OG001'}, {'value': '1.2621', 'spread': '0.2768', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1291', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wald Chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'zero inflated Poisson model: adjustment for centre and age \\[yrs\\] (zero model), treatment and race (Poisson model)'}, {'pValue': '0.0145', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wald Chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'zero inflated Poisson model: adjustment for centre and age \\[yrs\\] (zero model), treatment and race (Poisson model)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 12 months', 'description': 'A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age \\[years\\] and race were identified to be important beside treatment. The parameters centre and age \\[years\\] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.', 'unitOfMeasure': 'number of events per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.'}, {'type': 'SECONDARY', 'title': 'Growth Velocity as Assessed by Stadiometric Height Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.32', 'spread': '25.81', 'groupId': 'OG000'}, {'value': '64.60', 'spread': '27.31', 'groupId': 'OG001'}, {'value': '54.91', 'spread': '21.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months', 'description': 'Standing height measured in millimeters (mm) with a wall-mounted stadiometer.', 'unitOfMeasure': 'mm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Mean Rate of Asthma Exacerbations Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '1.366', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '1.310', 'groupId': 'OG001'}, {'value': '3.28', 'spread': '19.874', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4754', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6844', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months', 'description': 'Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).', 'unitOfMeasure': 'number of exacerbations per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.'}, {'type': 'SECONDARY', 'title': 'Duration of Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.17', 'spread': '6.198', 'groupId': 'OG000'}, {'value': '9.31', 'spread': '7.650', 'groupId': 'OG001'}, {'value': '7.92', 'spread': '4.061', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months', 'description': 'Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Exacerbations Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '1.025', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '1.028', 'groupId': 'OG001'}, {'value': '0.95', 'spread': '1.316', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months', 'description': 'The mean number of asthma exacerbations per participant is reported.', 'unitOfMeasure': 'exacerbations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Dropped-out Due to Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '4.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Change at Month 1 (n=78, 76, 81)', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.1715', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.1639', 'groupId': 'OG001'}, {'value': '0.012', 'spread': '0.1627', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2 (n=76, 73, 77)', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.1416', 'groupId': 'OG000'}, {'value': '0.060', 'spread': '0.1582', 'groupId': 'OG001'}, {'value': '0.005', 'spread': '0.1416', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4 (n=68, 72, 75)', 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.1483', 'groupId': 'OG000'}, {'value': '0.083', 'spread': '0.1486', 'groupId': 'OG001'}, {'value': '0.076', 'spread': '0.1725', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6 (n=67, 72, 72)', 'categories': [{'measurements': [{'value': '0.091', 'spread': '0.1714', 'groupId': 'OG000'}, {'value': '0.125', 'spread': '0.1975', 'groupId': 'OG001'}, {'value': '0.078', 'spread': '0.1855', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 8 (n=66, 71, 68)', 'categories': [{'measurements': [{'value': '0.075', 'spread': '0.2144', 'groupId': 'OG000'}, {'value': '0.126', 'spread': '0.2089', 'groupId': 'OG001'}, {'value': '0.120', 'spread': '0.1855', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 10 (n=66, 69, 67)', 'categories': [{'measurements': [{'value': '0.143', 'spread': '0.1458', 'groupId': 'OG000'}, {'value': '0.168', 'spread': '0.1910', 'groupId': 'OG001'}, {'value': '0.146', 'spread': '0.1609', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 12 (n=65, 69, 65)', 'categories': [{'measurements': [{'value': '0.161', 'spread': '0.2022', 'groupId': 'OG000'}, {'value': '0.185', 'spread': '0.2024', 'groupId': 'OG001'}, {'value': '0.178', 'spread': '0.1593', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Change at Month 1 (n=78, 76, 81)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '9.67', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '9.06', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2 (n=76, 73, 77)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '9.60', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '8.05', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4 (n=68, 72, 75)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '9.31', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '9.83', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6 (n=67, 72, 72)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '10.00', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '11.35', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '10.93', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 8 (n=66, 71, 68)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '12.44', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '12.25', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '10.24', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 10 (n=66, 69, 67)', 'categories': [{'measurements': [{'value': '8.6', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '10.48', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '9.22', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 12 (n=65, 69, 65)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '11.29', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '9.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'percent predicted FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 1, Evening PEF (n=78, 76, 80)', 'categories': [{'measurements': [{'value': '235.72', 'spread': '63.882', 'groupId': 'OG000'}, {'value': '238.16', 'spread': '52.565', 'groupId': 'OG001'}, {'value': '241.89', 'spread': '70.619', 'groupId': 'OG002'}]}]}, {'title': 'Month 1, Morning PEF (n=78, 76, 81)', 'categories': [{'measurements': [{'value': '232.09', 'spread': '64.933', 'groupId': 'OG000'}, {'value': '234.41', 'spread': '52.908', 'groupId': 'OG001'}, {'value': '233.81', 'spread': '66.039', 'groupId': 'OG002'}]}]}, {'title': 'Month 2, Evening PEF (n=76, 71, 77)', 'categories': [{'measurements': [{'value': '241.07', 'spread': '58.604', 'groupId': 'OG000'}, {'value': '241.16', 'spread': '50.422', 'groupId': 'OG001'}, {'value': '244.67', 'spread': '67.846', 'groupId': 'OG002'}]}]}, {'title': 'Month 2, Morning PEF (n=76, 72, 77)', 'categories': [{'measurements': [{'value': '236.92', 'spread': '61.243', 'groupId': 'OG000'}, {'value': '236.42', 'spread': '52.323', 'groupId': 'OG001'}, {'value': '239.07', 'spread': '70.132', 'groupId': 'OG002'}]}]}, {'title': 'Month 4, Evening PEF (n=68, 72, 75)', 'categories': [{'measurements': [{'value': '249.75', 'spread': '58.528', 'groupId': 'OG000'}, {'value': '243.52', 'spread': '49.076', 'groupId': 'OG001'}, {'value': '245.91', 'spread': '65.802', 'groupId': 'OG002'}]}]}, {'title': 'Month 4, Morning PEF (n=68, 71, 76)', 'categories': [{'measurements': [{'value': '242.93', 'spread': '56.658', 'groupId': 'OG000'}, {'value': '241.91', 'spread': '48.498', 'groupId': 'OG001'}, {'value': '240.16', 'spread': '65.211', 'groupId': 'OG002'}]}]}, {'title': 'Month 6, Evening PEF (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '251.88', 'spread': '60.255', 'groupId': 'OG000'}, {'value': '249.36', 'spread': '59.294', 'groupId': 'OG001'}, {'value': '246.44', 'spread': '63.946', 'groupId': 'OG002'}]}]}, {'title': 'Month 6, Morning PEF (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '246.44', 'spread': '59.781', 'groupId': 'OG000'}, {'value': '246.75', 'spread': '60.020', 'groupId': 'OG001'}, {'value': '238.81', 'spread': '63.419', 'groupId': 'OG002'}]}]}, {'title': 'Month 8, Evening PEF (n=66, 70, 69)', 'categories': [{'measurements': [{'value': '253.49', 'spread': '59.666', 'groupId': 'OG000'}, {'value': '250.92', 'spread': '51.376', 'groupId': 'OG001'}, {'value': '245.72', 'spread': '61.399', 'groupId': 'OG002'}]}]}, {'title': 'Month 8, Morning PEF (n=66, 71, 69)', 'categories': [{'measurements': [{'value': '247.24', 'spread': '59.806', 'groupId': 'OG000'}, {'value': '246.97', 'spread': '51.592', 'groupId': 'OG001'}, {'value': '239.73', 'spread': '61.733', 'groupId': 'OG002'}]}]}, {'title': 'Month 10, Evening PEF (n=65, 70, 68)', 'categories': [{'measurements': [{'value': '254.21', 'spread': '56.815', 'groupId': 'OG000'}, {'value': '256.44', 'spread': '56.469', 'groupId': 'OG001'}, {'value': '251.69', 'spread': '60.704', 'groupId': 'OG002'}]}]}, {'title': 'Month 10, Morning PEF (n=66, 70, 68)', 'categories': [{'measurements': [{'value': '247.94', 'spread': '60.418', 'groupId': 'OG000'}, {'value': '254.04', 'spread': '56.719', 'groupId': 'OG001'}, {'value': '246.23', 'spread': '62.805', 'groupId': 'OG002'}]}]}, {'title': 'Month 12, Evening PEF (n=68, 71, 70)', 'categories': [{'measurements': [{'value': '255.97', 'spread': '57.291', 'groupId': 'OG000'}, {'value': '263.87', 'spread': '58.469', 'groupId': 'OG001'}, {'value': '261.88', 'spread': '61.383', 'groupId': 'OG002'}]}]}, {'title': 'Month 12, Morning PEF (n=75, 73, 78)', 'categories': [{'measurements': [{'value': '245.84', 'spread': '59.834', 'groupId': 'OG000'}, {'value': '258.62', 'spread': '57.009', 'groupId': 'OG001'}, {'value': '250.55', 'spread': '63.204', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.', 'unitOfMeasure': 'liters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PEF by Diary Entries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Change at Month 1, Evening PEF (n=78, 76, 80)', 'categories': [{'measurements': [{'value': '8.46', 'spread': '17.952', 'groupId': 'OG000'}, {'value': '8.54', 'spread': '19.474', 'groupId': 'OG001'}, {'value': '6.06', 'spread': '39.183', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 1, Morning PEF (n=78, 76, 81)', 'categories': [{'measurements': [{'value': '11.69', 'spread': '21.268', 'groupId': 'OG000'}, {'value': '10.82', 'spread': '20.372', 'groupId': 'OG001'}, {'value': '7.54', 'spread': '25.697', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2, Evening PEF (n=76, 71, 77)', 'categories': [{'measurements': [{'value': '13.66', 'spread': '28.491', 'groupId': 'OG000'}, {'value': '13.04', 'spread': '20.890', 'groupId': 'OG001'}, {'value': '10.83', 'spread': '40.563', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2, Morning PEF (n=76, 72, 77)', 'categories': [{'measurements': [{'value': '17.12', 'spread': '32.068', 'groupId': 'OG000'}, {'value': '14.30', 'spread': '22.649', 'groupId': 'OG001'}, {'value': '14.29', 'spread': '37.228', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4, Evening PEF (n=68, 72, 75)', 'categories': [{'measurements': [{'value': '20.41', 'spread': '22.058', 'groupId': 'OG000'}, {'value': '16.01', 'spread': '21.547', 'groupId': 'OG001'}, {'value': '13.62', 'spread': '37.990', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4, Morning PEF (n=68, 71, 76)', 'categories': [{'measurements': [{'value': '21.33', 'spread': '26.603', 'groupId': 'OG000'}, {'value': '18.24', 'spread': '22.808', 'groupId': 'OG001'}, {'value': '16.28', 'spread': '34.841', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6, Evening PEF (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '22.44', 'spread': '28.236', 'groupId': 'OG000'}, {'value': '21.86', 'spread': '38.280', 'groupId': 'OG001'}, {'value': '13.14', 'spread': '33.321', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6, Morning PEF (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '24.82', 'spread': '30.613', 'groupId': 'OG000'}, {'value': '24.68', 'spread': '40.981', 'groupId': 'OG001'}, {'value': '14.44', 'spread': '29.950', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 8, Evening PEF (n=66, 70, 69)', 'categories': [{'measurements': [{'value': '25.47', 'spread': '27.430', 'groupId': 'OG000'}, {'value': '21.38', 'spread': '28.648', 'groupId': 'OG001'}, {'value': '13.30', 'spread': '37.061', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 8, Morning PEF (n=66, 71, 69)', 'categories': [{'measurements': [{'value': '27.16', 'spread': '32.530', 'groupId': 'OG000'}, {'value': '23.76', 'spread': '29.089', 'groupId': 'OG001'}, {'value': '16.03', 'spread': '34.017', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 10, Evening PEF (n=65, 70, 68)', 'categories': [{'measurements': [{'value': '25.68', 'spread': '30.945', 'groupId': 'OG000'}, {'value': '26.78', 'spread': '34.255', 'groupId': 'OG001'}, {'value': '18.04', 'spread': '38.209', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 10, Morning PEF (n=66, 70, 68)', 'categories': [{'measurements': [{'value': '27.86', 'spread': '38.406', 'groupId': 'OG000'}, {'value': '29.84', 'spread': '36.390', 'groupId': 'OG001'}, {'value': '21.25', 'spread': '34.940', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 12, Evening PEF (n=68, 71, 70)', 'categories': [{'measurements': [{'value': '28.24', 'spread': '28.811', 'groupId': 'OG000'}, {'value': '33.35', 'spread': '38.772', 'groupId': 'OG001'}, {'value': '25.38', 'spread': '43.284', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 12, Morning PEF (n=75, 73, 78)', 'categories': [{'measurements': [{'value': '26.84', 'spread': '32.932', 'groupId': 'OG000'}, {'value': '34.31', 'spread': '41.166', 'groupId': 'OG001'}, {'value': '24.37', 'spread': '39.312', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'liters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diurnal PEF Fluctuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Change at Month 1 (n=78, 76, 80)', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '3.970', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '3.772', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '3.867', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 2 (n=76, 71, 77)', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '5.009', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '4.131', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '5.084', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 4 (n=68, 71, 75)', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '5.251', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '3.784', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '4.421', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 6 (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '-1.01', 'spread': '4.351', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '5.860', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '4.280', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 8 (n=66, 70, 69)', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '4.830', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '3.757', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '4.048', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 10 (n=64, 70, 68)', 'categories': [{'measurements': [{'value': '-1.46', 'spread': '5.221', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '4.319', 'groupId': 'OG001'}, {'value': '-1.14', 'spread': '4.059', 'groupId': 'OG002'}]}]}, {'title': 'Change at Month 12 (n=68, 70, 70)', 'categories': [{'measurements': [{'value': '-1.81', 'spread': '4.913', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '4.440', 'groupId': 'OG001'}, {'value': '-1.26', 'spread': '4.187', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'Diurnal PEF Fluctuation is equal to \\[(Higher PEF - Lower PEF)/0.5\\*(Higher PEF + Lower PEF)\\] \\* 100%. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'percent fluctuation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Total Asthma Symptom Score by Diary Entries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 1 (n=77, 75, 79)', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.489', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.329', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.535', 'groupId': 'OG002'}]}]}, {'title': 'Month 2 (n=76, 70, 77)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.246', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '0.484', 'groupId': 'OG002'}]}]}, {'title': 'Month 4 (n=68, 72, 75)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.178', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.359', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.289', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.294', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.289', 'groupId': 'OG002'}]}]}, {'title': 'Month 8 (n=66, 69, 69)', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.283', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.243', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.414', 'groupId': 'OG002'}]}]}, {'title': 'Month 10 (n=64, 70, 68)', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.253', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.227', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.490', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=68, 69, 70)', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.240', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.129', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.338', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 1 (n=78, 75, 80)', 'categories': [{'measurements': [{'value': '2.40', 'spread': '6.159', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '4.256', 'groupId': 'OG001'}, {'value': '1.85', 'spread': '4.223', 'groupId': 'OG002'}]}]}, {'title': 'Month 2 (n=76, 73, 77)', 'categories': [{'measurements': [{'value': '1.96', 'spread': '5.877', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '2.364', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '4.662', 'groupId': 'OG002'}]}]}, {'title': 'Month 4 (n=68, 72, 75)', 'categories': [{'measurements': [{'value': '1.33', 'spread': '4.017', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '2.139', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '4.106', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '0.87', 'spread': '2.527', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '3.288', 'groupId': 'OG001'}, {'value': '1.26', 'spread': '3.235', 'groupId': 'OG002'}]}]}, {'title': 'Month 8 (n=66, 70, 69)', 'categories': [{'measurements': [{'value': '1.62', 'spread': '4.129', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '2.823', 'groupId': 'OG001'}, {'value': '1.82', 'spread': '5.024', 'groupId': 'OG002'}]}]}, {'title': 'Month 10 (n=66, 70, 68)', 'categories': [{'measurements': [{'value': '1.93', 'spread': '7.106', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '2.220', 'groupId': 'OG001'}, {'value': '1.88', 'spread': '5.468', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=74, 73, 78)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '1.554', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '11.769', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '1.853', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary.", 'unitOfMeasure': 'percentage of nights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Use Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 1 (n=57, 51, 54)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.345', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '1.148', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.910', 'groupId': 'OG002'}]}]}, {'title': 'Month 2 (n=53, 40, 46)', 'categories': [{'measurements': [{'value': '0.99', 'spread': '1.296', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.728', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '1.298', 'groupId': 'OG002'}]}]}, {'title': 'Month 4 (n=48, 47, 51)', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.300', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '1.595', 'groupId': 'OG001'}, {'value': '1.27', 'spread': '1.984', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=45, 43, 44)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.084', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.329', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '1.583', 'groupId': 'OG002'}]}]}, {'title': 'Month 8 (n=38, 42, 45)', 'categories': [{'measurements': [{'value': '1.01', 'spread': '1.530', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '1.950', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '1.219', 'groupId': 'OG002'}]}]}, {'title': 'Month 10 (n=38, 41, 39)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '1.423', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '1.243', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '1.113', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=36, 40, 40)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.897', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '1.360', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '1.152', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary.", 'unitOfMeasure': 'puffs/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Rescue Medication Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 1 (n=55, 53, 54)', 'categories': [{'measurements': [{'value': '47.94', 'spread': '44.405', 'groupId': 'OG000'}, {'value': '47.34', 'spread': '44.984', 'groupId': 'OG001'}, {'value': '44.37', 'spread': '45.367', 'groupId': 'OG002'}]}]}, {'title': 'Month 2 (n=52, 41, 48)', 'categories': [{'measurements': [{'value': '48.78', 'spread': '46.442', 'groupId': 'OG000'}, {'value': '54.46', 'spread': '46.668', 'groupId': 'OG001'}, {'value': '45.31', 'spread': '47.761', 'groupId': 'OG002'}]}]}, {'title': 'Month 4 (n=49, 48, 52)', 'categories': [{'measurements': [{'value': '49.91', 'spread': '48.274', 'groupId': 'OG000'}, {'value': '46.51', 'spread': '45.209', 'groupId': 'OG001'}, {'value': '45.91', 'spread': '46.328', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=47, 44, 45)', 'categories': [{'measurements': [{'value': '49.63', 'spread': '48.084', 'groupId': 'OG000'}, {'value': '48.14', 'spread': '45.321', 'groupId': 'OG001'}, {'value': '49.42', 'spread': '47.515', 'groupId': 'OG002'}]}]}, {'title': 'Month 8 (n=39, 42, 44)', 'categories': [{'measurements': [{'value': '47.93', 'spread': '45.170', 'groupId': 'OG000'}, {'value': '50.50', 'spread': '46.100', 'groupId': 'OG001'}, {'value': '45.22', 'spread': '45.002', 'groupId': 'OG002'}]}]}, {'title': 'Month 10 (n=40, 40, 37)', 'categories': [{'measurements': [{'value': '46.22', 'spread': '47.901', 'groupId': 'OG000'}, {'value': '49.78', 'spread': '48.521', 'groupId': 'OG001'}, {'value': '52.70', 'spread': '46.015', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=35, 41, 40)', 'categories': [{'measurements': [{'value': '53.58', 'spread': '47.785', 'groupId': 'OG000'}, {'value': '53.63', 'spread': '48.358', 'groupId': 'OG001'}, {'value': '58.03', 'spread': '46.264', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Days without use of rescue medication documented in the participant's diary were reported.", 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Asthma Symptom Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 1 (n=62, 60, 60)', 'categories': [{'measurements': [{'value': '37.32', 'spread': '40.983', 'groupId': 'OG000'}, {'value': '36.95', 'spread': '42.207', 'groupId': 'OG001'}, {'value': '35.00', 'spread': '43.032', 'groupId': 'OG002'}]}]}, {'title': 'Month 2 (n=61, 50, 56)', 'categories': [{'measurements': [{'value': '38.47', 'spread': '44.743', 'groupId': 'OG000'}, {'value': '41.16', 'spread': '44.738', 'groupId': 'OG001'}, {'value': '33.56', 'spread': '44.161', 'groupId': 'OG002'}]}]}, {'title': 'Month 4 (n=54,55, 59)', 'categories': [{'measurements': [{'value': '42.57', 'spread': '46.573', 'groupId': 'OG000'}, {'value': '38.83', 'spread': '44.042', 'groupId': 'OG001'}, {'value': '35.78', 'spread': '43.538', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=53, 50, 51)', 'categories': [{'measurements': [{'value': '41.75', 'spread': '46.474', 'groupId': 'OG000'}, {'value': '39.87', 'spread': '43.744', 'groupId': 'OG001'}, {'value': '40.09', 'spread': '45.274', 'groupId': 'OG002'}]}]}, {'title': 'Month 8 (n=46, 46, 46)', 'categories': [{'measurements': [{'value': '38.86', 'spread': '43.312', 'groupId': 'OG000'}, {'value': '43.90', 'spread': '45.377', 'groupId': 'OG001'}, {'value': '40.03', 'spread': '43.369', 'groupId': 'OG002'}]}]}, {'title': 'Month 10 (n=43, 47, 44)', 'categories': [{'measurements': [{'value': '41.00', 'spread': '46.575', 'groupId': 'OG000'}, {'value': '41.65', 'spread': '47.435', 'groupId': 'OG001'}, {'value': '39.83', 'spread': '44.332', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=42, 44, 45)', 'categories': [{'measurements': [{'value': '43.20', 'spread': '46.787', 'groupId': 'OG000'}, {'value': '42.03', 'spread': '47.093', 'groupId': 'OG001'}, {'value': '44.61', 'spread': '46.120', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Days without Asthma Symptom documented in the participant's diary were reported.", 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 2 (n=70, 73, 75)', 'categories': [{'measurements': [{'value': '6.21', 'spread': '0.979', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '0.878', 'groupId': 'OG001'}, {'value': '6.08', 'spread': '1.031', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=65, 72, 72)', 'categories': [{'measurements': [{'value': '6.33', 'spread': '0.874', 'groupId': 'OG000'}, {'value': '6.26', 'spread': '0.982', 'groupId': 'OG001'}, {'value': '6.30', 'spread': '0.933', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=64, 69, 65)', 'categories': [{'measurements': [{'value': '6.42', 'spread': '0.786', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '0.946', 'groupId': 'OG001'}, {'value': '6.36', 'spread': '0.824', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 2, 6 and 12', 'description': 'The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where "1" indicated maximum impairment and "7" indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': "Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Month 2 (n=73, 73, 76)', 'categories': [{'measurements': [{'value': '5.87', 'spread': '1.196', 'groupId': 'OG000'}, {'value': '6.16', 'spread': '1.033', 'groupId': 'OG001'}, {'value': '6.08', 'spread': '1.078', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=67, 72, 73)', 'categories': [{'measurements': [{'value': '6.15', 'spread': '1.005', 'groupId': 'OG000'}, {'value': '6.16', 'spread': '1.115', 'groupId': 'OG001'}, {'value': '6.31', 'spread': '0.927', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=66, 69, 66)', 'categories': [{'measurements': [{'value': '6.32', 'spread': '0.849', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '0.712', 'groupId': 'OG001'}, {'value': '6.31', 'spread': '0.899', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 2, 6 and 12', 'description': 'The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby "1" indicated maximum impairment and "7" indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Vital Signs Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure \\>130 mmHg or \\<80 mmHg or a \\>20 mmHg difference from Baseline; Diastolic Blood Pressure \\> 85 mmHg; and Resting Heart Rate \\>140 bpm or \\<60 bpm or a \\>30 bpm difference from Baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': 'Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin \\<9.5 g/dL; Erythrocytes \\<3.0 x 10\\^6/μL or \\>6.5 x 10\\^6/μL; White Blood Count \\<3000/mm\\^3 or \\>20000/mm\\^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose \\>2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase \\>3 times ULNR; Creatinine \\>1.5 times ULN; Potassium \\>5.0 mmol/L or \\<3.0 mmol/L; and Sodium \\>150 mmol/L or 130 mmol/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', '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. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of trial medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'FG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 30 investigative sites in Canada, Hungary and South Africa from 24 January 2005 to 25 June 2009.', 'preAssignmentDetails': 'Children who experienced symptoms consistent with mild asthma for at least 12 months were enrolled in 1 of 3 treatment groups: once a day placebo, 100 µg or 200 µg ciclesonide.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'BG001', 'title': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '2.06', 'groupId': 'BG000'}, {'value': '7.7', 'spread': '1.84', 'groupId': 'BG001'}, {'value': '8.1', 'spread': '2.19', 'groupId': 'BG002'}, {'value': '7.9', 'spread': '2.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '29.90', 'spread': '9.701', 'groupId': 'BG000'}, {'value': '30.01', 'spread': '9.247', 'groupId': 'BG001'}, {'value': '33.13', 'spread': '11.640', 'groupId': 'BG002'}, {'value': '31.08', 'spread': '10.365', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Weight data was only available for n=77, 76, 84 participants, respectively.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '17.30', 'spread': '3.107', 'groupId': 'BG000'}, {'value': '17.69', 'spread': '2.977', 'groupId': 'BG001'}, {'value': '18.68', 'spread': '4.069', 'groupId': 'BG002'}, {'value': '17.91', 'spread': '3.478', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'BMI data was only available for n=77, 76, 84 participants, respectively.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification (Non-smoker)', 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2010-07-01', 'completionDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2005-09-12', 'dispFirstSubmitQcDate': '2010-07-01', 'resultsFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2005-09-12', 'dispFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-01', 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Asthma Exacerbation', 'timeFrame': 'Up to 12 months', 'description': 'Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug.'}, {'measure': 'Exacerbations (Post-hoc Analysis of Annual Rates)', 'timeFrame': 'Up to 12 months', 'description': 'A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age \\[years\\] and race were identified to be important beside treatment. The parameters centre and age \\[years\\] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.'}], 'secondaryOutcomes': [{'measure': 'Growth Velocity as Assessed by Stadiometric Height Measurement', 'timeFrame': 'Up to 12 months', 'description': 'Standing height measured in millimeters (mm) with a wall-mounted stadiometer.'}, {'measure': 'Mean Rate of Asthma Exacerbations Per Year', 'timeFrame': 'Up to 12 months', 'description': 'Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).'}, {'measure': 'Duration of Exacerbations', 'timeFrame': 'Up to 12 months', 'description': 'Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.'}, {'measure': 'Number of Exacerbations Per Participant', 'timeFrame': 'Up to 12 months', 'description': 'The mean number of asthma exacerbations per participant is reported.'}, {'measure': 'Percentage of Participants Who Dropped-out Due to Asthma Exacerbation', 'timeFrame': 'Up to 12 months'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.'}, {'measure': 'Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.'}, {'measure': 'Change From Baseline in PEF by Diary Entries', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Diurnal PEF Fluctuation', 'timeFrame': 'Baseline and Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'Diurnal PEF Fluctuation is equal to \\[(Higher PEF - Lower PEF)/0.5\\*(Higher PEF + Lower PEF)\\] \\* 100%. A positive change from Baseline indicates improvement.'}, {'measure': 'Total Asthma Symptom Score by Diary Entries', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': 'Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual.'}, {'measure': 'Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary."}, {'measure': 'Rescue Medication Use Per Day', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary."}, {'measure': 'Percentage of Rescue Medication Free Days', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Days without use of rescue medication documented in the participant's diary were reported."}, {'measure': 'Percentage of Asthma Symptom Free Days', 'timeFrame': 'Months 1, 2, 4, 6, 8, 10 and 12', 'description': "Days without Asthma Symptom documented in the participant's diary were reported."}, {'measure': 'Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])', 'timeFrame': 'Months 2, 6 and 12', 'description': 'The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where "1" indicated maximum impairment and "7" indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best).'}, {'measure': "Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)", 'timeFrame': 'Months 2, 6 and 12', 'description': 'The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby "1" indicated maximum impairment and "7" indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best).'}, {'measure': 'Number of Participants With Clinically Significant Vital Signs Findings', 'timeFrame': 'Up to 12 months', 'description': 'Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure \\>130 mmHg or \\<80 mmHg or a \\>20 mmHg difference from Baseline; Diastolic Blood Pressure \\> 85 mmHg; and Resting Heart Rate \\>140 bpm or \\<60 bpm or a \\>30 bpm difference from Baseline.'}, {'measure': 'Number of Participants With Clinically Significant Physical Examination Findings', 'timeFrame': 'Up to 12 months', 'description': 'A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Values', 'timeFrame': 'Up to 12 months', 'description': 'Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin \\<9.5 g/dL; Erythrocytes \\<3.0 x 10\\^6/μL or \\>6.5 x 10\\^6/μL; White Blood Count \\<3000/mm\\^3 or \\>20000/mm\\^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose \\>2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase \\>3 times ULNR; Creatinine \\>1.5 times ULN; Potassium \\>5.0 mmol/L or \\<3.0 mmol/L; and Sodium \\>150 mmol/L or 130 mmol/L.'}, {'measure': 'Number of Participants With Adverse Events and Serious Adverse Events', 'timeFrame': 'Up to 12 months', '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. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Ciclesonide', 'Exacerbation'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.', 'detailedDescription': 'The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma.\n\nThe study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):\n\n* Ciclesonide 100 µg\n* Ciclesonide 200 µg\n* Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient.\n\nAll participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months.\n\nThis multi-center trial was conducted in Canada, Hungary and South Africa. The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Outpatients\n* Symptoms consistent with the diagnosis of asthma for at least 12 months\n* Forced Expiratory Volume in one Second (FEV) at least 80% of predicted\n* Participants who have a history of reversible airway obstruction\n* Good health with the exception of asthma\n\nMain Exclusion Criteria:\n\n* History of life-threatening asthma\n* A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year\n* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids\n* Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)\n* Prematurely born children (\\<36 weeks of gestation)\n* Smokers\n* Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential'}, 'identificationModule': {'nctId': 'NCT00163293', 'acronym': 'POPCICLE', 'briefTitle': 'Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations', 'orgStudyIdInfo': {'id': 'BY9010/CA-101'}, 'secondaryIdInfos': [{'id': '2007-003736-34', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1189-7814', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciclesonide 100 µg', 'description': 'Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.', 'interventionNames': ['Drug: Ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciclesonide 200 µg', 'description': 'Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.', 'interventionNames': ['Drug: Ciclesonide']}], 'interventions': [{'name': 'Ciclesonide', 'type': 'DRUG', 'otherNames': ['Alvesco®'], 'description': 'Ciclesonide metered-dose inhaler', 'armGroupLabels': ['Ciclesonide 100 µg', 'Ciclesonide 200 µg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Ciclesonide placebo-matching metered-dose inhaler', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2T5C7', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'J1H 5M4', 'city': 'Fleurimont', 'country': 'Canada', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}, {'zip': 'N6C 4Y7', 'city': 'London', 'country': 'Canada', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6A1V2', 'city': 'London,ON', 'country': 'Canada', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'R3A1R9', 'city': 'Winnipeg', 'country': 'Canada', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'AstraZeneca AstraZeneca', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}