Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-01-11 @ 5:10 AM
Study NCT ID:
NCT00112359
Status:
COMPLETED
Last Update Posted:
2011-04-21
First Post:
2005-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D011552', 'term': 'Pseudomonas Infections'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.bresnik@gilead.com', 'phone': '(650) 522-5934', 'title': 'Mark Bresnik, MD, Director, Clinical Research', 'organization': 'Gilead Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'Institution and investigator may publish or present the results of the trial generated there with prior written consent of Gilead; or 2 years after the trial has ended at all institutions. Proposed publications/target venue must go to Gilead 30 days (manuscripts) or 15 days (abstracts/presentations) prior. Any Gilead confidential information in the document(s) must be deleted, or if requested publication delayed for up to 45 days to permit Gilead to obtain intellectual property protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs that first occurred or worsened after the first dose of study drug through 30 days after the last dose are summarized.', 'description': 'An AE was any physical or clinical worsening in symptoms or disease (including clinically significant change in lab values) experienced by participant at any time during the study, whether or not the event was considered related to study participation or study procedures.\n\nParticipants were only counted once within an SOC and preferred term.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.', 'otherNumAtRisk': 84, 'otherNumAffected': 67, 'seriousNumAtRisk': 84, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.', 'otherNumAtRisk': 80, 'otherNumAffected': 63, 'seriousNumAtRisk': 80, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 38}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Crackles lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 8}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}], 'seriousEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Breath sounds decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Crackles lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspnoea exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Intercostal retraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 8.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change in CFQ-R RSS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.976', 'spread': '1.624', 'groupId': 'OG000'}, {'value': '7.007', 'spread': '1.647', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.98', 'ciLowerLimit': '3.50', 'ciUpperLimit': '12.47', 'pValueComment': 'No adjustments were made for multiple comparisons.', 'groupDescription': 'Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 14.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \\>50% or \\<=50% pred.). Treatment differences: AZLI-placebo.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Day 14', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Change in CFQ-R RSS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.711', 'spread': '1.849', 'groupId': 'OG000'}, {'value': '0.618', 'spread': '1.875', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0154', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.33', 'ciLowerLimit': '1.22', 'ciUpperLimit': '11.43', 'pValueComment': 'No adjustments were made for multiple comparisons.', 'groupDescription': 'Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 42.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \\>50% or \\<=50% pred.). Treatment differences: AZLI-placebo.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Day 42', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.', 'anticipatedPostingDate': '2010-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Other Pathogens Present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'title': 'Staphylococcus aureus - Day 0', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus aureus - Day 28', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Burkholderia cepacia - Day 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Burkholderia cepacia - Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stenotrophomonas maltophilia - Day 0', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stenotrophomonas maltophilia - Day 28', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Achromobacter xylosoxidans - Day 0', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Achromobacter xylosoxidans - Day 28', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 28', 'description': 'Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'PA isolates', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'title': 'Day 0 MIC50', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Day 0 MIC90', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.\n\nMIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).\n\nMIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).\n\nMIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.', 'unitOfMeasure': 'μg/mL', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'PA isolates', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percent Change in FEV1 (L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.408', 'spread': '1.466', 'groupId': 'OG000'}, {'value': '7.886', 'spread': '1.481', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.294', 'ciLowerLimit': '6.288', 'ciUpperLimit': '14.299', 'pValueComment': 'Analysis based on two-sided test with an 0.025 a priori threshold for statistical significance as part of the methods used to control the family-wise type 1 error.', 'groupDescription': 'Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in percent change in FEV1 at Day 28.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included treatment, disease severity (FEV1 \\>50% or \\<=50% pred.), and Day 0 FEV1. Treatment differences: AZLI-placebo.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Day 28', 'description': 'Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28.', 'unitOfMeasure': 'Percent change in FEV1 (L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.069', 'spread': '0.231', 'groupId': 'OG000'}, {'value': '-1.384', 'spread': '0.247', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.453', 'ciLowerLimit': '-2.115', 'ciUpperLimit': '-0.791', 'pValueComment': 'Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.', 'groupDescription': 'Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change in log10 PA CFUs in sputum at Day 28.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment and disease severity (FEV1 \\>50% or \\<=50% pred.). Treatment differences calculated as AZLI-placebo.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Day 28', 'description': 'Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.', 'unitOfMeasure': 'Log10 PA CFUs/gram of sputum', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants randomized to treatment who received at least part of 1 dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2364', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.', 'groupDescription': 'Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Comparison by treatment for proportion of subjects using additional (nonprotocol-specified) antipseudomonal antibiotics at least once during study.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 42', 'description': 'Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received.', 'anticipatedPostingDate': '2010-03'}, {'type': 'PRIMARY', 'title': 'Change in CFQ-R Respiratory Symptoms Scale (RSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.63', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '7.08', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.71', 'ciLowerLimit': '4.31', 'ciUpperLimit': '15.11', 'pValueComment': 'Primary endpoint analysis based on 2-sided test with an 0.05 a priori threshold for statistical significance.\n\nA gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints.', 'groupDescription': 'Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.\n\nA sample size of 70 participants per treatment group provided approximately 77% power to detect an 8-point difference in CFQ-R RSS score between treatment groups, assuming a standard deviation (SD) of 20 and a Type I error rate of 0.05.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model includes treatment, baseline CFQ-R RSS, and disease severity (FEV1 \\>50% or \\<=50% pred.). Treatment differences: AZLI-placebo.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Day 28', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Number of Participants Hospitalized at Least Once Between Day 0 and Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0640', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '0', 'pValueComment': 'No adjustments were made for multiple comparisons.', 'groupDescription': 'Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants hospitalized at least once during the study.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Comparison by treatment group for proportion of participants hospitalized at least once between Day 0 and Day 42 (or 14 days after last study dose).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 42', 'description': 'Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'units': 'PA isolates', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'OG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'classes': [{'title': 'Day 28 MIC50', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 MIC90', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.\n\nMIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).\n\nMIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).\n\nMIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.', 'unitOfMeasure': 'μg/mL', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'PA isolates', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'FG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Unrelated adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Trial drug intolerance (adverse event)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Personal/administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Phase 3, double-blind, multicenter, multinational, randomized, placebo-controlled trial evaluating AZLI in patients with CF and PA. Participants were enrolled at 53 sites total: 40 in United States, 5 in Canada, 7 in Australia, and 1 in New Zealand. Date of first enrollment was 10 Jun 2005, and date of last participant follow-up was 3 Apr 2007.', 'preAssignmentDetails': 'Planned study size was 140 participants to be randomized in a 1:1 ratio to AZLI or placebo TID, with 166 actually randomized (83 AZLI, 83 placebo). However, two participants did not receive a dose of drug, and one participant randomized to receive AZLI received placebo in error. Thus, 80 participants received AZLI and 84 received placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo TID', 'description': 'Placebo (5 mg/mL lactose when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.'}, {'id': 'BG001', 'title': '75 mg AZLI TID', 'description': 'AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \\[0.17% saline\\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease severity based on forced expiratory volume in 1 second (FEV1) % predicted', 'classes': [{'title': 'Disease severity: FEV1 > 50% predicted', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Disease severity: FEV1 <= 50% predicted', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. This baseline measure indicates the number of subjects with FEV1 greater than 50% and less than or equal to 50% of the predicted value based on age, gender, and height at screening.', 'unitOfMeasure': 'participants'}]}}, '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': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-21', 'studyFirstSubmitDate': '2005-06-01', 'resultsFirstSubmitDate': '2010-09-10', 'studyFirstSubmitQcDate': '2005-06-01', 'lastUpdatePostDateStruct': {'date': '2011-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-21', 'studyFirstPostDateStruct': {'date': '2005-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Other Pathogens Present', 'timeFrame': 'Day 0 to Day 28', 'description': 'Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans.'}, {'measure': 'Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)', 'timeFrame': 'Day 0', 'description': 'PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.\n\nMIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).\n\nMIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).\n\nMIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.'}, {'measure': 'Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)', 'timeFrame': 'Day 28', 'description': 'PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.\n\nMIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).\n\nMIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).\n\nMIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.'}], 'primaryOutcomes': [{'measure': 'Change in CFQ-R Respiratory Symptoms Scale (RSS) Score', 'timeFrame': 'Day 0 to Day 28', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).'}], 'secondaryOutcomes': [{'measure': 'Change in CFQ-R RSS Score', 'timeFrame': 'Day 0 to Day 14', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).'}, {'measure': 'Change in CFQ-R RSS Score', 'timeFrame': 'Day 0 to Day 42', 'description': 'The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).'}, {'measure': 'Percent Change in FEV1 (L)', 'timeFrame': 'Day 0 to Day 28', 'description': 'Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28.'}, {'measure': 'Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum', 'timeFrame': 'Day 0 to Day 28', 'description': 'Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.'}, {'measure': 'Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug', 'timeFrame': 'Day 0 to Day 42', 'description': 'Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF.'}, {'measure': 'Number of Participants Hospitalized at Least Once Between Day 0 and Day 42', 'timeFrame': 'Day 0 to Day 42', 'description': 'Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'Pseudomonas aeruginosa', 'Pulmonary Cystic Fibrosis'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '19420195', 'type': 'DERIVED', 'citation': 'Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, Cooper PJ. Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis. Chest. 2009 May;135(5):1223-1232. doi: 10.1378/chest.08-1421.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).', 'detailedDescription': 'CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered TID using the PARI eFlow® electronic nebulizer, in CF patients with PA.\n\nIn this study, participant eligibility was assessed at a screening visit 7 to 14 days prior to the baseline visit (Day 0). Those participants who continued to meet eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI TID or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow-up visit 14 days after the last dose of study drug (Day 42).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:\n\n * Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT);\n * Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or\n * Abnormal nasal potential difference.\n* PA present in expectorated sputum or throat swab culture at Screening.\n* FEV1 between (and including) 25% and 75% predicted at Screening.\n* Negative pregnancy test at Screening.\n* Ability to perform reproducible pulmonary function tests.\n* Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Administration of antipseudomonal antibiotics by inhalation, IV, or oral routes (including azithromycin) within 14 days of Screening.\n* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.\n* History of sputum or throat swab culture yielding Burkholderia cepacia in the previous 2 years.\n* History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.\n* Administration of any investigational drug or use of any investigational device within 28 days of Screening and within 6 half-lives of the investigational drug (whichever was longer).\n* Known local or systemic hypersensitivity to monobactam antibiotics.\n* Inability to tolerate short-acting bronchodilator use at least three times daily.\n* Changes in protocol-permitted antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days prior to Screening or between Screening and the next visit.\n* Changes in physiotherapy technique or schedule within 7 days prior to Screening or between Screening and the next visit.\n* History of lung transplantation.\n* A chest x-ray indicating abnormal findings at Screening or within the previous 90 days.\n* Abnormal renal or hepatic function at Screening.\n* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.\n* Use of aerosolized hypertonic saline (except for sputum induction) during the 14 days preceding Visit 1.'}, 'identificationModule': {'nctId': 'NCT00112359', 'acronym': 'AIR-CF1', 'briefTitle': 'International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)', 'orgStudyIdInfo': {'id': 'CP-AI-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo three times a day (TID)', 'interventionNames': ['Drug: Placebo three times a day (TID)']}, {'type': 'EXPERIMENTAL', 'label': 'AZLI 75 mg three times a day (TID)', 'interventionNames': ['Drug: AZLI 75 mg three times a day (TID)']}], 'interventions': [{'name': 'AZLI 75 mg three times a day (TID)', 'type': 'DRUG', 'armGroupLabels': ['AZLI 75 mg three times a day (TID)']}, {'name': 'Placebo three times a day (TID)', 'type': 'DRUG', 'armGroupLabels': ['Placebo three times a day (TID)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Pediatric Breathing Disorders Clinic', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital, Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Capital Allergy and Respiratory Disease Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Sciences Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic, Orlando", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital / Northwestern University", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi - St. Francis Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Central Maine Pulmonary Associates', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Children's Lung Specialists", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'St. Barnabas Healthcare System', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical College', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pediatric Pulmonary Associates, South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Martha Foster Lung Care Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Alamo Clinical Research Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pediatric Pulmonary Center/Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Prahran', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}, {'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Princess Margaret Hospital for Children', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Capital Health and the Governors of the University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brian Lyttle Professional Corporation', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland District Health Board', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Bruce Montgomery, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corus Pharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Bresnik, MD, Director, Clinical Research', 'oldOrganization': 'Gilead Sciences, Inc.'}}}}