Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT02106832
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'Bayer acknowledges and accepts the interest in the non-commercial scientific publication of Results. In a multi-center study the Principal Investigators will not make any publication of the results before the first multi-center publication. Proposed publication/presentation shall be provided to Bayer at least 60 days prior to the intended submission or presentation of the publication in order to allow Bayer to review it. Any difference of opinion shall be discussed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study treatment up to 30 days after the last study drug administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).', 'otherNumAtRisk': 171, 'otherNumAffected': 51, 'seriousNumAtRisk': 171, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).', 'otherNumAtRisk': 174, 'otherNumAffected': 60, 'seriousNumAtRisk': 174, 'seriousNumAffected': 45}, {'id': 'EG002', 'title': 'Pooled Placebo', 'description': 'Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).', 'otherNumAtRisk': 174, 'otherNumAffected': 55, 'seriousNumAtRisk': 174, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 41, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oesophageal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Glottis carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 31, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 174, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Pooled Placebo', 'description': 'Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Value cannot be estimated due to censored data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Value cannot be estimated due to censored data.', 'groupId': 'OG001', 'lowerLimit': '211', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0511', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.9', 'paramValue': '0.7062', 'ciLowerLimit': '0.3928', 'ciUpperLimit': '1.2698', 'groupDescription': 'The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.', 'statisticalMethod': 'Wald-type test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 48', 'description': 'Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.', 'unitOfMeasure': 'Days', 'dispersionType': '99.9% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).'}], 'classes': [{'title': 'Number of exacerbations: 0', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 1', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).'}], 'classes': [{'title': 'Number of exacerbations: 0', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Number of exacerbations: 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48', 'description': 'For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}, {'value': '40.2', 'groupId': 'OG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}, {'value': '31.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (Week 44/46)', 'description': 'Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included participants who were randomized.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG002', 'title': 'Placebo 28 Days on/Off (Placebo 28)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).'}, {'id': 'OG003', 'title': 'Placebo 14 Days on/Off (Placebo 14)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.92', 'spread': '21.06', 'groupId': 'OG000'}, {'value': '-9.02', 'spread': '20.10', 'groupId': 'OG001'}, {'value': '-2.91', 'spread': '24.48', 'groupId': 'OG002'}, {'value': '-11.50', 'spread': '18.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (Week 44/46)', 'description': 'The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}, {'value': '61.5', 'groupId': 'OG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (Week 44/46)', 'description': 'New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG002', 'title': 'Placebo 28 Days on/Off (Placebo 28)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).'}, {'id': 'OG003', 'title': 'Placebo 14 Days on/Off (Placebo 14)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.57', 'spread': '17.49', 'groupId': 'OG000'}, {'value': '10.90', 'spread': '18.07', 'groupId': 'OG001'}, {'value': '7.08', 'spread': '17.00', 'groupId': 'OG002'}, {'value': '10.70', 'spread': '15.58', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (Week 44/46)', 'description': 'The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'OG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG002', 'title': 'Placebo 28 Days on/Off (Placebo 28)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).'}, {'id': 'OG003', 'title': 'Placebo 14 Days on/Off (Placebo 14)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.038', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.287', 'groupId': 'OG001'}, {'value': '-0.038', 'spread': '0.272', 'groupId': 'OG002'}, {'value': '0.037', 'spread': '0.299', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of treatment (Week 44/46)', 'description': 'FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS with participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'OG001', 'title': 'Pooled Placebo', 'description': 'Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Value cannot be estimated due to censored data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Value cannot be estimated due to censored data.', 'groupId': 'OG001', 'lowerLimit': '278', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3965', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '0.8662', 'ciLowerLimit': '0.6206', 'ciUpperLimit': '1.2090', 'groupDescription': 'The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.', 'statisticalMethod': 'Wald-type test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 48', 'description': 'Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.', 'unitOfMeasure': 'Days', 'dispersionType': '95.1% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included participants who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'FG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'FG002', 'title': 'Placebo 28 Days on/Off (Placebo 28)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).'}, {'id': 'FG003', 'title': 'Placebo 14 Days on/Off (Placebo 14)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Deterioration of general conditions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study was conducted at 164 study centers in 25 countries between 30 April 2014 (first subject first visit) and 19 October 2016 (last subject last visit).', 'preAssignmentDetails': 'A total of 1123 subjects were screened and 521 subjects were randomized. The randomized subjects were allocated to treatment groups, and 2 subjects in the Cipro 14 group did not receive study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '521', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciprofloxacin DPI 28 Days on/Off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).'}, {'id': 'BG001', 'title': 'Ciprofloxacin DPI 14 Days on/Off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).'}, {'id': 'BG002', 'title': 'Placebo 28 Days on/Off (Placebo 28)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).'}, {'id': 'BG003', 'title': 'Placebo 14 Days on/Off (Placebo 14)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '60.4', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '13.7', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '15.0', 'groupId': 'BG003'}, {'value': '60.1', 'spread': '14.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '302', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score", 'classes': [{'categories': [{'measurements': [{'value': '60.75', 'spread': '20.61', 'groupId': 'BG000'}, {'value': '61.26', 'spread': '19.54', 'groupId': 'BG001'}, {'value': '58.56', 'spread': '19.17', 'groupId': 'BG002'}, {'value': '63.47', 'spread': '19.48', 'groupId': 'BG003'}, {'value': '61.00', 'spread': '19.82', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this baseline measure, the symptoms component score was reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score', 'classes': [{'categories': [{'measurements': [{'value': '50.14', 'spread': '19.07', 'groupId': 'BG000'}, {'value': '52.17', 'spread': '18.49', 'groupId': 'BG001'}, {'value': '53.95', 'spread': '16.00', 'groupId': 'BG002'}, {'value': '48.67', 'spread': '17.72', 'groupId': 'BG003'}, {'value': '51.22', 'spread': '18.16', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this baseline measure, the respiratory symptoms domain score was reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced Expiratory Volume in One Second (FEV1)', 'classes': [{'categories': [{'measurements': [{'value': '1.569', 'spread': '0.602', 'groupId': 'BG000'}, {'value': '1.519', 'spread': '0.617', 'groupId': 'BG001'}, {'value': '1.560', 'spread': '0.692', 'groupId': 'BG002'}, {'value': '1.477', 'spread': '0.558', 'groupId': 'BG003'}, {'value': '1.535', 'spread': '0.615', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).', 'unitOfMeasure': 'Liter', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 521}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-04', 'studyFirstSubmitDate': '2014-04-04', 'resultsFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-02', 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo', 'timeFrame': 'Up to Week 48', 'description': 'Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.'}, {'measure': 'Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo', 'timeFrame': 'Up to Week 48', 'description': 'Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks', 'timeFrame': 'Up to Week 48', 'description': 'For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.'}, {'measure': 'Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks', 'timeFrame': 'Up to Week 48', 'description': 'For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.'}, {'measure': 'Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)', 'timeFrame': 'End of treatment (Week 44/46)', 'description': 'Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.'}, {'measure': "Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)", 'timeFrame': 'Baseline and end of treatment (Week 44/46)', 'description': 'The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.'}, {'measure': 'Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)', 'timeFrame': 'End of treatment (Week 44/46)', 'description': 'New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.'}, {'measure': 'Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)', 'timeFrame': 'Baseline and end of treatment (Week 44/46)', 'description': 'The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.'}, {'measure': 'Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)', 'timeFrame': 'Baseline and end of treatment (Week 44/46)', 'description': 'FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ciprofloxacin', 'Dry Powder for Inhalation', 'Exacerbation', 'Bronchiectasis'], 'conditions': ['Bronchiectasis']}, 'referencesModule': {'references': [{'pmid': '29371384', 'type': 'DERIVED', 'citation': 'Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702053. doi: 10.1183/13993003.02053-2017. Print 2018 Jan.'}, {'pmid': '28495619', 'type': 'DERIVED', 'citation': 'Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.', 'detailedDescription': 'Number of participants with Adverse events will be covered in Adverse Events section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a proven and documented diagnosis of non CF idiopathic or post infectious bronchiectasis\n* Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks\n\nExclusion Criteria:\n\n* Forced expiratory volume in 1 second (FEV1) \\<30% or \\>90% predicted\n* Active allergic bronchopulmonary aspergillosis\n* Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis\n* Primary diagnosis of Chronic obstructive pulmonary disease (COPD)'}, 'identificationModule': {'nctId': 'NCT02106832', 'acronym': 'RESPIRE 2', 'briefTitle': 'Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.', 'orgStudyIdInfo': {'id': '15626'}, 'secondaryIdInfos': [{'id': '2013-004659-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ciprofloxacin DPI 28 Days on/off (Cipro 28)', 'description': 'Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).', 'interventionNames': ['Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Ciprofloxacin DPI 14 Days on/off (Cipro 14)', 'description': 'Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).', 'interventionNames': ['Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 28 Days on/off (Placebo 28)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 14 Days on/off (Placebo 14)', 'description': 'Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ciprofloxacin (BAYQ3939) dry powder for inhalation', 'type': 'DRUG', 'description': 'Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.', 'armGroupLabels': ['Ciprofloxacin DPI 28 Days on/off (Cipro 28)']}, {'name': 'Ciprofloxacin (BAYQ3939) dry powder for inhalation', 'type': 'DRUG', 'description': 'Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.', 'armGroupLabels': ['Ciprofloxacin DPI 14 Days on/off (Cipro 14)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off', 'armGroupLabels': ['Placebo 28 Days on/off (Placebo 28)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off', 'armGroupLabels': ['Placebo 14 Days on/off (Placebo 14)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': 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