Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT01019694
Status:
COMPLETED
Last Update Posted:
2014-10-23
First Post:
2009-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease
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': 'D000068600', 'term': 'Albuterol, Ipratropium Drug Combination'}, {'id': 'D009241', 'term': 'Ipratropium'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'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': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug intake until one day after last drug intake', 'eventGroups': [{'id': 'EG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)', 'otherNumAtRisk': 157, 'otherNumAffected': 68, 'seriousNumAtRisk': 157, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid', 'otherNumAtRisk': 154, 'otherNumAffected': 76, 'seriousNumAtRisk': 154, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid', 'otherNumAtRisk': 154, 'otherNumAffected': 71, 'seriousNumAtRisk': 154, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}], 'seriousEvents': [{'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Pituitary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Inguinal hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cardiac enzymes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Electrocardiogram T wave inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Non-small cell lung cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Ovarian fibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '87.9', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '81.7', 'spread': '1.37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '6.02', 'ciUpperLimit': '13.19', 'groupDescription': 'Comparison of 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The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '78.0', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '76.3', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '7.9', 'ciLowerLimit': '4.71', 'ciUpperLimit': '11.09', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '6.44', 'ciUpperLimit': '12.83', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '86.6', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '77.5', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '78.9', 'spread': '1.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '9.2', 'ciLowerLimit': '5.94', 'ciUpperLimit': '12.37', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '7.7', 'ciLowerLimit': '4.44', 'ciUpperLimit': '10.96', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '76.9', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '80.5', 'spread': '1.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '7.90', 'ciUpperLimit': '14.76', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '7.7', 'ciLowerLimit': '4.23', 'ciUpperLimit': '11.23', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '36 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '1.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.42', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '0.0026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.59', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2826', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.38', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.66', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.59', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.71', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.65', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.20', 'ciUpperLimit': '0.68', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '36 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.47', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '0.0245', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.54', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '48 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 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False}, {'pValue': '0.3093', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.09', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3578', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.11', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '0.7433', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.25', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.524', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.15', 'groupDescription': 'Comparison of Combivent Respimat versus Combivent Inhalation Aerosol', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '0.3171', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.11', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 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'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}, {'pValue': '0.3755', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.65', 'groupDescription': 'Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline and baseline-by-test-day interaction', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '48 weeks', 'description': 'Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48', 'unitOfMeasure': 'number of puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '118', 'spread': '118', 'groupId': 'OG000'}, {'value': '113', 'spread': '113', 'groupId': 'OG001'}, {'value': '110', 'spread': '110', 'groupId': 'OG002'}]}]}, {'title': '1 exacerbation', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': '2 exacerbations', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '3 exacerbations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '4 exacerbations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '5 or more exacerbations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}, {'type': 'SECONDARY', 'title': 'Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'OG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'OG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '147', 'spread': '147', 'groupId': 'OG000'}, {'value': '148', 'spread': '148', 'groupId': 'OG001'}, {'value': '146', 'spread': '146', 'groupId': 'OG002'}]}]}, {'title': '1 exacerbation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': '2 exacerbations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '3 or more exacerbations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set is defined as all patients who were randomized and received study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'FG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'FG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 pats. in Comb. Inh. Aero. and 3 pats. in Atro+Alb not treated and excluded from the Treated Set', 'groupId': 'FG000', 'numSubjects': '157'}, {'comment': '2 pats. in Comb. Inh. Aero. and 3 pats. in Atro+Alb not treated and excluded from the Treated Set', 'groupId': 'FG001', 'numSubjects': '156'}, {'comment': '2 pats. in Comb. Inh. Aero. and 3 pats. in Atro+Alb not treated and excluded from the Treated Set', 'groupId': 'FG002', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Other reason (not specified)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '465', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Combivent Respimat', 'description': 'ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)'}, {'id': 'BG001', 'title': 'Combivent Inhalation Aerosol', 'description': 'ipratropium bromide and albuterol sulfate 36/206 mcg qid'}, {'id': 'BG002', 'title': 'Atrovent + Albuterol Aerosols', 'description': 'ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '62.9', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '>= 40 to < 65 years', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '263', 'groupId': 'BG003'}]}]}, {'title': '>= 65 to < 75 years', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '273', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black / African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '435', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.6', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '170.6', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '171.1', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '170.8', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking History', 'classes': [{'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}]}]}, {'title': 'Currently smokes', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking History (pack years)', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '24.5', 'groupId': 'BG000'}, {'value': '53.6', 'spread': '29.7', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '25.4', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '26.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pack years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chronic Obstructive Pulmonary Disease (COPD) Duration', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '7.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '5.8', 'groupId': 'BG002'}, {'value': '7.6', 'spread': '6.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 470}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2009-11-16', 'resultsFirstSubmitDate': '2012-04-05', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-05', 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48', 'timeFrame': '48 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).'}], 'secondaryOutcomes': [{'measure': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3', 'timeFrame': '3 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).'}, {'measure': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12', 'timeFrame': '12 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).'}, {'measure': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24', 'timeFrame': '24 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).'}, {'measure': 'Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36', 'timeFrame': '36 weeks', 'description': 'Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).'}, {'measure': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0', 'timeFrame': '0 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).'}, {'measure': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3', 'timeFrame': '3 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).'}, {'measure': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12', 'timeFrame': '12 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).'}, {'measure': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24', 'timeFrame': '24 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).'}, {'measure': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36', 'timeFrame': '36 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).'}, {'measure': 'Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48', 'timeFrame': '48 weeks', 'description': 'Patient satisfaction was assessed by asking: "Overall, how satisfied are you with your inhaler?". Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied).'}, {'measure': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0', 'timeFrame': '0 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).'}, {'measure': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3', 'timeFrame': '3 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).'}, {'measure': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12', 'timeFrame': '12 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).'}, {'measure': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24', 'timeFrame': '24 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).'}, {'measure': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36', 'timeFrame': '36 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).'}, {'measure': 'Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48', 'timeFrame': '48 weeks', 'description': 'CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).'}, {'measure': "Physician's Global Evaluation at Week 0", 'timeFrame': '0 weeks', 'description': 'Physicians evaluated the patient\'s overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).'}, {'measure': "Physician's Global Evaluation at Week 3", 'timeFrame': '3 weeks', 'description': 'Physicians evaluated the patient\'s overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).'}, {'measure': "Physician's Global Evaluation at Week 12", 'timeFrame': '12 weeks', 'description': 'Physicians evaluated the patient\'s overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).'}, {'measure': "Physician's Global Evaluation at Week 24", 'timeFrame': '24 weeks', 'description': 'Physicians evaluated the patient\'s overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).'}, {'measure': "Physician's Global Evaluation at Week 36", 'timeFrame': '36 weeks', 'description': 'Physicians evaluated the patient\'s overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).'}, {'measure': "Physician's Global Evaluation at Week 48", 'timeFrame': '48 weeks', 'description': 'Physicians evaluated the patient\'s overall clinical condition on a scale ranging from "poor" (score 1 or 2) to "excellent" (score 7 or 8).'}, {'measure': 'Change From Baseline in FEV1 at Day 1', 'timeFrame': 'baseline, day 1', 'description': 'Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.'}, {'measure': 'Change From Baseline in FEV1 at Week 12', 'timeFrame': 'baseline, 12 weeks', 'description': 'Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12'}, {'measure': 'Change From Baseline in FEV1 at Week 24', 'timeFrame': 'baseline, 24 weeks', 'description': 'Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24'}, {'measure': 'Change From Baseline in FEV1 at Week 48', 'timeFrame': 'baseline, 48 weeks', 'description': 'Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48'}, {'measure': 'Change From Baseline in FVC at Day 1', 'timeFrame': 'baseline, day 1', 'description': 'Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.'}, {'measure': 'Change From Baseline in FVC at Week 12', 'timeFrame': 'baseline, 12 weeks', 'description': 'Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12'}, {'measure': 'Change From Baseline in FVC at Week 24', 'timeFrame': 'baseline, 24 weeks', 'description': 'Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24'}, {'measure': 'Change From Baseline in FVC at Week 48', 'timeFrame': 'baseline, 48 weeks', 'description': 'Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48'}, {'measure': 'Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0', 'timeFrame': '0 weeks', 'description': 'Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0'}, {'measure': 'Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3', 'timeFrame': '3 weeks', 'description': 'Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3'}, {'measure': 'Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12', 'timeFrame': '12 weeks', 'description': 'Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12'}, {'measure': 'Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24', 'timeFrame': '24 weeks', 'description': 'Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24'}, {'measure': 'Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36', 'timeFrame': '36 weeks', 'description': 'Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36'}, {'measure': 'Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48', 'timeFrame': '48 weeks', 'description': 'Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48'}, {'measure': 'Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'timeFrame': '48 weeks'}, {'measure': 'Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization', 'timeFrame': '48 weeks'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '23658479', 'type': 'DERIVED', 'citation': 'Ferguson GT, Ghafouri M, Dai L, Dunn LJ. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. Int J Chron Obstruct Pulmon Dis. 2013;8:139-50. doi: 10.2147/COPD.S38577. Epub 2013 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. All patients must sign an informed consent consistent with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines prior to participation in the trial.\n2. Male or female patients 40 years of age or older.\n3. Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded) Pack Years = Number of cigarettes/day x years of smoking 20 cigarettes/pack\n4. All patients must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (P95-4381), and must meet the following spirometric criteria at Visit 1:Relatively stable, moderate to severe airway obstruction with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \\< 80% of predicted normal and FEV1/Forced Vital Capacity (FVC) \\< 70%. Spirometry should be done at baseline and approximately 1/2 hour following 4 inhalations of albuterol. Predicted normal values will be calculated according to European Coal and Steel Community (ECSC), European Community for Coal and Steel (ECCS), (R94-1408). For Height measured in inches Males: FEV1 predicted (L) = 4.30 x \\[height (inches) / 39.37\\]-0.029 x age (yrs) - 2.49 Females: FEV1 predicted (L) = 3.95 x \\[height (inches) / 39.37\\]-0.025 x age (yrs) - 2.60 For Height measured in meters Males: FEV1 predicted (L) = 4.30 x \\[height (meters)\\] - 0.029 x age (years) -2.49 Females: FEV1 predicted (L) = 3.95 x \\[height (meters)\\] - 0.025 x age (years) - 2.60\n5. Patients must be able to perform all study related procedures and maintain study records during the study period as required in the protocol.\n6. Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).\n\nExclusion criteria:\n\n1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.\n2. Patients with a recent history (i.e., one year or less) of myocardial infarction.\n3. Patients who have been hospitalized or being treated for heart failure within the past year.\n4. Patients with clinically unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy within the past year.\n5. Patients with a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with fully cured squamous cell or treated basal cell carcinoma are allowed).\n6. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.\n7. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.\n8. Patients with a current diagnosis of asthma.\n9. Patients with a history of significant alcohol or drug abuse.\n10. Patients with known active tuberculosis.\n11. Patients using beta blocker medications are excluded. Cardioselective beta blockers are allowed with caution. Beta blocker eye medications for treatment of non-narrow angle glaucoma are allowed.\n12. Patients who regularly use daytime oxygen therapy for more than 1 hour per day Continuous Positive Airway Pressure (CPAP for sleep apnea is allowed).\n13. Patients using oral corticosteroid medication at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, except as required for treatment of exacerbation during the study.\n14. Pregnant or nursing women.\n15. Women of childbearing potential not using a medically approved means of contraception (i.e., oral or injectable contraceptives, intrauterine devices or diaphragm with spermicide, or transdermal hormonal patches). Abstinence will not be accepted as a medically approved means of contraception. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.\n16. Patients with known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide/albuterol RESPIMAT solution including Benzalkonium chloride (BAC) and Ethylenediaminetetraacetic acid (EDTA) or the ipratropium bromide/albuterol Chlorofluorocarbons (CFC) MDI or Hydrofluoroalkane (HFA) components.\n17. Previous participation in this study. (The patient cannot re-enroll into this study.)\n18. Patients who are currently participating in another interventional study.\n19. Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening.\n20. Patients currently in any pulmonary rehabilitation program or scheduled to participate in any such program during the study period."}, 'identificationModule': {'nctId': 'NCT01019694', 'briefTitle': 'Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Patient Acceptability of Ipratropium Bromide/Albuteroll Delivered by the Respimat® Inhaler in Adults With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '1012.62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combivent Respimat 20/100 microgram(mcg)', 'description': 'patient to take 1 inhalation 4 times a day', 'interventionNames': ['Drug: Combivent Respimat 20/100 mcg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combivent CFC-MDI 36/206 microgram-mcg', 'description': 'patient to take 2 inhalations 4 times a day', 'interventionNames': ['Drug: Combivent CFC-MDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atrovent HFA 42 mcg + Albuterol HFA', 'description': 'patient to take 2 inhalations of each 4 times a day', 'interventionNames': ['Drug: Atrovent HFA 42 mcg + Albuterol HFA 200 mcg']}], 'interventions': [{'name': 'Combivent CFC-MDI', 'type': 'DRUG', 'description': '36/206 mcg Four times a day (QID)', 'armGroupLabels': ['Combivent CFC-MDI 36/206 microgram-mcg']}, {'name': 'Combivent Respimat 20/100 mcg', 'type': 'DRUG', 'description': 'Open label randomized parallel', 'armGroupLabels': ['Combivent Respimat 20/100 microgram(mcg)']}, {'name': 'Atrovent HFA 42 mcg + Albuterol HFA 200 mcg', 'type': 'DRUG', 'description': 'Open label randomized parallel', 'armGroupLabels': ['Atrovent HFA 42 mcg + Albuterol HFA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': '1012.62.153 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, 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