Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01415518
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2011-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}, {'id': 'D009241', 'term': 'Ipratropium'}, {'id': 'D013806', 'term': 'Theophylline'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Goran Eckerwall', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "PI shall not publish any results until the earlier of (i) the date of the first Study results publication authorized by AZ and (ii) the end of the 18 month period following the completion of the Study. PI shall provide AZ with such material for review, at least 60 days prior to submission for publication. If requested in writing by AZ, PI shall withhold material from submission for publication for an additional 90 days from the date of AZ's request.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)', 'otherNumAtRisk': 293, 'otherNumAffected': 33, 'seriousNumAtRisk': 293, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)', 'otherNumAtRisk': 289, 'otherNumAffected': 31, 'seriousNumAtRisk': 289, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 293, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre-dose FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.079', 'groupId': 'OG000', 'lowerLimit': '1.059', 'upperLimit': '1.100'}, {'value': '1.009', 'groupId': 'OG001', 'lowerLimit': '0.990', 'upperLimit': '1.029'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.069', 'ciLowerLimit': '1.043', 'ciUpperLimit': '1.096', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug', 'description': 'Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Post-dose FEV1 at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.179', 'groupId': 'OG000', 'lowerLimit': '1.161', 'upperLimit': '1.199'}, {'value': '1.106', 'groupId': 'OG001', 'lowerLimit': '1.088', 'upperLimit': '1.124'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.067', 'ciLowerLimit': '1.044', 'ciUpperLimit': '1.090', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug', 'description': 'Ratio of post-dose FEV1 at 5 minutes to baseline value', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Post-dose FEV1 at 60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.219', 'groupId': 'OG000', 'lowerLimit': '1.199', 'upperLimit': '1.240'}, {'value': '1.142', 'groupId': 'OG001', 'lowerLimit': '1.123', 'upperLimit': 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'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.404', 'groupId': 'OG000', 'lowerLimit': '-0.539', 'upperLimit': '-0.268'}, {'value': '-0.061', 'groupId': 'OG001', 'lowerLimit': '-0.197', 'upperLimit': '0.075'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.342', 'ciLowerLimit': '-0.523', 'ciUpperLimit': '-0.162', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period (12 weeks)', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period', 'unitOfMeasure': 'times/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in COPD Symptoms - Breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.507', 'groupId': 'OG000', 'lowerLimit': '-0.584', 'upperLimit': '-0.431'}, {'value': '-0.229', 'groupId': 'OG001', 'lowerLimit': '-0.305', 'upperLimit': '-0.152'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.279', 'ciLowerLimit': '-0.381', 'ciUpperLimit': '-0.177', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)', 'description': 'Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period', 'unitOfMeasure': 'Score from 0 to 4', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COPD Symptoms - Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.441', 'groupId': 'OG000', 'lowerLimit': '-0.516', 'upperLimit': '-0.365'}, {'value': '-0.248', 'groupId': 'OG001', 'lowerLimit': '-0.324', 'upperLimit': '-0.172'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.193', 'ciLowerLimit': '-0.294', 'ciUpperLimit': '-0.092', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)', 'description': 'Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period', 'unitOfMeasure': 'Score from 0 to 4', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COPD Symptoms Sputum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.332', 'groupId': 'OG000', 'lowerLimit': '-0.407', 'upperLimit': '-0.257'}, {'value': '-0.124', 'groupId': 'OG001', 'lowerLimit': '-0.200', 'upperLimit': '-0.049'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.208', 'ciLowerLimit': '-0.308', 'ciUpperLimit': '-0.108', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)', 'description': 'Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period', 'unitOfMeasure': 'Score from 0 to 4', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.069', 'groupId': 'OG000', 'lowerLimit': '0.044', 'upperLimit': '0.106'}, {'value': '0.121', 'groupId': 'OG001', 'lowerLimit': '0.087', 'upperLimit': '0.170'}]}]}], 'analyses': [{'pValue': '0.0425', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.565', 'ciLowerLimit': '0.325', 'ciUpperLimit': '0.981', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Poisson regression model with treatment as a factor and the duration time in study as an offset variable'}, {'pValue': '0.0880', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.604', 'ciLowerLimit': '0.339', 'ciUpperLimit': '1.078', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Time to the first COPD exacerbation'}, {'pValue': '0.0845', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Time to the first COPD exacerbation'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Whole treatment period (12 weeks)', 'description': 'Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms', 'unitOfMeasure': 'exacerbations/12 weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Reliever Medication During Night in the Last Week on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.078', 'groupId': 'OG000', 'lowerLimit': '-0.147', 'upperLimit': '-0.009'}, {'value': '-0.023', 'groupId': 'OG001', 'lowerLimit': '-0.093', 'upperLimit': '0.046'}]}]}], 'analyses': [{'pValue': '0.2281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.055', 'ciLowerLimit': '-0.144', 'ciUpperLimit': '0.035', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the last week on treatment', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period', 'unitOfMeasure': 'times/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Reliever Medication During Night in the First Week on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.124', 'groupId': 'OG000', 'lowerLimit': '-0.179', 'upperLimit': '-0.068'}, {'value': '-0.002', 'groupId': 'OG001', 'lowerLimit': '-0.057', 'upperLimit': '0.053'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.122', 'ciLowerLimit': '-0.194', 'ciUpperLimit': '-0.049', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment', 'description': 'change in the number of inhalations of reliever medication during day from run-in to the first week on treatment', 'unitOfMeasure': 'times/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Reliever Medication During Night in the Whole Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'OG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.086', 'groupId': 'OG000', 'lowerLimit': '-0.144', 'upperLimit': '-0.027'}, {'value': '0.020', 'groupId': 'OG001', 'lowerLimit': '-0.038', 'upperLimit': '0.079'}]}]}], 'analyses': [{'pValue': '0.0073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.106', 'ciLowerLimit': '-0.183', 'ciUpperLimit': '-0.029', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the whole treatment period (12 weeks)', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period', 'unitOfMeasure': 'times/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'FG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '292'}]}, {'type': 'Patients Who Received Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'groupId': 'FG001', 'numSubjects': '292'}]}, {'type': 'Pts With Correct Randomized Treatment', 'achievements': [{'comment': 'Efficacy analysis used 290 patients. Safety analysis used 290+3=293 patients.', 'groupId': 'FG000', 'numSubjects': '290'}, {'comment': 'Efficacy analysis used 292 patients. Safety analysis used 292-3=289 patients.', 'groupId': 'FG001', 'numSubjects': '289'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '261'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Condition under Investigation Worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symbicort Turbuhaler + Ipratropium + Theophylline SR', 'description': 'Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'BG001', 'title': 'Ipratropium + Theophylline SR', 'description': 'ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '8.79', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '8.76', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '8.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Two patients in 'Symbicort Turbuhaler + ipratropium + theophylline' group did not receive study treatment and were excluded from the analysis popolation. Thus the number of patients in that group is 290 (= 290 - 2)."}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 581}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-28', 'studyFirstSubmitDate': '2011-08-08', 'resultsFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-11', 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-dose FEV1', 'timeFrame': 'Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug', 'description': 'Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value'}], 'secondaryOutcomes': [{'measure': 'Post-dose FEV1 at 5 Minutes', 'timeFrame': 'Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug', 'description': 'Ratio of post-dose FEV1 at 5 minutes to baseline value'}, {'measure': 'Post-dose FEV1 at 60 Minutes', 'timeFrame': 'Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)', 'description': 'Ratio of post-dose FEV1 at 60 minutes to baseline value'}, {'measure': 'Pre-dose FVC', 'timeFrame': 'Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)', 'description': 'Ratio of pre-dose FVC (Forced Vital Capacity) to baseline'}, {'measure': 'Post-dose FVC at 5 Minutes', 'timeFrame': 'Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)', 'description': 'Ratio of post-dose FVC at 5 minutes to baseline'}, {'measure': 'Post-dose FVC at 60 Minutes', 'timeFrame': 'Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)', 'description': 'Ratio of post-dose FVC at 60 minutes to baseline'}, {'measure': 'Pre-dose IC', 'timeFrame': 'Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)', 'description': 'Ratio of pre-dose IC (Inspiratory Capacity) to baseline'}, {'measure': 'Post-dose IC at 60 Minutes', 'timeFrame': 'Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)', 'description': 'Ratio of post-dose IC at 60 minutes to baseline'}, {'measure': 'Pre-dose PEF in Last Week of Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment', 'description': 'Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment'}, {'measure': 'Pre-dose PEF in First Week of Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured before inhalation of study drug in the first week of treatment', 'description': 'Change in pre-dose morning PEF from run-in period to first week of treatment'}, {'measure': 'Pre-dose PEF in Whole Treatment Period', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period (12 weeks)', 'description': 'Change in pre-dose morning PEF from run-in period to whole treatment period'}, {'measure': 'Post-dose PEF in Last Week of Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment', 'description': 'Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment'}, {'measure': 'Post-dose PEF in First Week of Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured at 5 minutes after inhalation of study drug in the first week of treatment', 'description': 'Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment'}, {'measure': 'Post-dose PEF in Whole Treatment Period', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period (12 weeks)', 'description': 'Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period'}, {'measure': 'Use of Reliever Medication During Day in the Last Week on Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the last week on treatment'}, {'measure': 'Use of Reliever Medication During Day in the First Week on Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the first week on treatment'}, {'measure': 'Use of Reliever Medication During Day in the Whole Treatment Period', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period (12 weeks)', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period'}, {'measure': 'Change in COPD Symptoms - Breathing', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)', 'description': 'Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period'}, {'measure': 'COPD Symptoms - Cough', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)', 'description': 'Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period'}, {'measure': 'COPD Symptoms Sputum', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)', 'description': 'Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period'}, {'measure': 'COPD Exacerbations', 'timeFrame': 'Whole treatment period (12 weeks)', 'description': 'Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms'}, {'measure': 'Use of Reliever Medication During Night in the Last Week on Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the last week on treatment', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period'}, {'measure': 'Use of Reliever Medication During Night in the First Week on Treatment', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment', 'description': 'change in the number of inhalations of reliever medication during day from run-in to the first week on treatment'}, {'measure': 'Use of Reliever Medication During Night in the Whole Treatment Period', 'timeFrame': 'Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the whole treatment period (12 weeks)', 'description': 'Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period'}]}, 'conditionsModule': {'keywords': ['Severe chronic obstructive pulmonary disease (COPD) patients'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D589BL00022&attachmentIdentifier=2a7ff667-339c-456d-8acc-8e6f547b9c3d&fileName=D589BL00022_Clinical_Study_Protocol_REDACTED.pdf&versionIdentifier=', 'label': 'Clinical Study Protocol'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D589BL00022&attachmentIdentifier=816840bb-da84-40c7-b174-fa5951b2c915&fileName=D589BL00022_SECURE2_Synopsis_1_0_20131126_v2.0001-v4.pdf&versionIdentifier=', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.', 'detailedDescription': 'Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, 1 tablet p.o. twice daily) compared with Atrovent + theophylline SR in severe COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent\n* Men or women patients ≥ 40 years of age\n* Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2\n* Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \\< 70%, pre-bronchodilator\n* Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period\n\nExclusion Criteria:\n\n* A history of asthma and seasonal allergic rhinitis before 40 years of age\n* Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period\n* Patients with relevant cardiovascular disorder judged by the investigator\n* Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator\n* Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator'}, 'identificationModule': {'nctId': 'NCT01415518', 'acronym': 'SECURE2', 'briefTitle': 'Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Efficacy and Tolerability Study of Symbicort Turbuhaler(160/4.5µg/Inhalation,2inhalations Twice Daily) Added to Atrovent (20µg/Inhalation, 2 Inhalations 4 Times Daily)+Theophylline SR(0.1g/Tablet,1 Tablet p.o. Twice Daily) Compared With Atrovent+Theophylline SR in Severe COPD Patients.', 'orgStudyIdInfo': {'id': 'D589BL00022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)', 'interventionNames': ['Drug: Drug: Budesonide/formoterol (Symbicort Turbuhaler', 'Drug: Drug: ipratropium (AtroventTM)', 'Drug: theophylline SR']}, {'type': 'OTHER', 'label': '2', 'description': 'ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)', 'interventionNames': ['Drug: Drug: ipratropium (AtroventTM)', 'Drug: theophylline SR']}], 'interventions': [{'name': 'Drug: Budesonide/formoterol (Symbicort Turbuhaler', 'type': 'DRUG', 'description': 'budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)', 'armGroupLabels': ['1']}, {'name': 'Drug: ipratropium (AtroventTM)', 'type': 'DRUG', 'description': 'ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)', 'armGroupLabels': ['1', '2']}, {'name': 'theophylline SR', 'type': 'DRUG', 'description': 'theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Tangshan', 'state': 'Hebei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Chengdu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqin', 'country': 'China', 'facility': 'Research Site'}, {'city': 'Dalian', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': "Ha'er BING", 'country': 'China', 'facility': 'Research Site'}, {'city': 'Hohhot', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}], 'overallOfficials': [{'name': 'Samuel Chen', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca Singapore Pte Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}