Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT00104520
Status:
COMPLETED
Last Update Posted:
2011-03-11
First Post:
2005-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
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}, 'limitationsAndCaveats': {'description': 'The study was designed such that participants were discontinued from study participation upon meeting the primary endpoint (time to need for inhaled or IV antipseudomonal antibiotics).'}}, 'adverseEventsModule': {'timeFrame': 'AEs that first occurred or worsened after the first dose of study drug through 30 days after the last dose (Day 0 to Day 56) 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 treatment period of study, whether or not event was considered related to study participation or procedures. Participants were only counted once within an SOC and preferred term.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.', 'otherNumAtRisk': 76, 'otherNumAffected': 65, 'seriousNumAtRisk': 76, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.', 'otherNumAtRisk': 135, 'otherNumAffected': 121, 'seriousNumAtRisk': 135, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 81}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Crackles lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Dyspnoea exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 11}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 14}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 49}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 16}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}], 'seriousEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Chest X-ray abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Crackles lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Neurological symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Spinal cord injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDra 8.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDra 8.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'OG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '97'}, {'value': '92', 'comment': 'NA = not estimable', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0070', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '0', 'pValueComment': 'Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.', 'groupDescription': 'H0: no difference between AZLI and placebo (pooled treatment groups) in time to need for inhaled or IV antibiotics. Assuming 2-sided significance level of 0.05, \\~210 subjects (70 in each AZLI group, 35 in each placebo group) provided \\>90% power to reject null hypothesis based on Lakatos normal approximation method with weights being one. Therefore, 250 subjects were to be randomized at Visit 2 (Day -28) to ensure at least 210 participants entered double-blind treatment period at Day 0.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0 to Day 84 (end of study)', 'description': 'The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on intents to treat (ITT) population (all participants randomized to treatment who received at least part of one dose of study drug).', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'OG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.66', 'spread': '1.708', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.01', 'ciLowerLimit': '0.81', 'ciUpperLimit': '9.21', 'pValueComment': 'No adjustments were made for multiple comparisons.', 'groupDescription': 'Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in change from baseline in CFQ-R RSS scores.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Day 28', 'description': 'The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores \\[units\\]: 0-100; higher scores indicate fewer symptoms).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants randomized to tx who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to AE or study drug intolerance. For all other missing data, LOCF method was used.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'OG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.363', 'spread': '1.534', 'groupId': 'OG000'}, {'value': '3.917', 'spread': '1.151', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.280', 'ciLowerLimit': '2.500', 'ciUpperLimit': '10.060', 'pValueComment': 'No adjustments were made for multiple comparisons.', 'groupDescription': 'Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in percent change from baseline in FEV1 (L).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment and baseline value.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Day 28', 'description': 'Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines.\n\nFEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second.\n\nThe percent change in this parameter from Day 0 to Day 28 was determined for each treatment group.', 'unitOfMeasure': 'Percent change in FEV1 (L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalization Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'OG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 to Day 84', 'description': 'Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.', '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': '57', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'OG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.225', 'spread': '0.209', 'groupId': 'OG000'}, {'value': '-0.434', 'spread': '0.167', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.659', 'ciLowerLimit': '-1.125', 'ciUpperLimit': '-0.193', 'groupDescription': 'Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in mean change from baseline in log10 PA CFUs in sputum.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (\\<=2, 4-8, 16-128 or \\>=256 μg/mL) value.', '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 one dose of study drug). No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Other Pathogens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'OG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'classes': [{'title': 'S. aureus - Day 0', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'S. aureus - Day 28', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'B. cepacia - Day 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'B. cepacia - Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'S. maltophilia - Day 0', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'S. maltophilia - Day 28', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'A. xylosoxidans - Day 0', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'A. xylosoxidans - Day 28', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 and Day 28', 'description': 'Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans.\n\nNumber of participants with other pathogens at baseline and at the end of treatment (28 days) are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'OG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'classes': [{'title': 'Baseline MIC50', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 MIC50', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline MIC90', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 MIC90', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 28', 'description': 'The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed.\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', 'populationDescription': 'Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.', 'anticipatedPostingDate': '2010-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'FG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '71'}]}], 'dropWithdraws': [{'type': 'Unrelated adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Study drug intolerance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Related adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Personal/administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 56 sites in the United States. Date of first enrollment was 24 February 2005, and date of last participant follow-up was 07 September 2006.', 'preAssignmentDetails': 'Subjects were randomized in 1:1:2:2 ratio to placebo twice a day (BID) or three times a day (TID) and AZLI BID or TID, respectively. A total of 211 subjects were included in the ITT analyses: 38 placebo BID, 38 placebo TID, 69 AZLI BID, and 66 AZLI TID. All analyses were conducted on pooled placebo (n = 76) versus pooled AZLI (n = 135) groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (Pooled BID/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 twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'BG001', 'title': 'AZLI (Pooled BID/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 BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '25.3', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2005-03-01', 'resultsFirstSubmitDate': '2010-09-10', 'studyFirstSubmitQcDate': '2005-03-01', 'lastUpdatePostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-16', 'studyFirstPostDateStruct': {'date': '2005-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Other Pathogens', 'timeFrame': 'Day 0 and Day 28', 'description': 'Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans.\n\nNumber of participants with other pathogens at baseline and at the end of treatment (28 days) are reported.'}, {'measure': 'Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)', 'timeFrame': 'Day 0 to Day 28', 'description': 'The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed.\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': 'Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics', 'timeFrame': 'Day 0 to Day 84 (end of study)', 'description': 'The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.'}], 'secondaryOutcomes': [{'measure': 'Change in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score', 'timeFrame': 'Day 0 to Day 28', 'description': 'The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores \\[units\\]: 0-100; higher scores indicate fewer symptoms).'}, {'measure': 'Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)', 'timeFrame': 'Day 0 to Day 28', 'description': 'Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines.\n\nFEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second.\n\nThe percent change in this parameter from Day 0 to Day 28 was determined for each treatment group.'}, {'measure': 'Number of Hospitalization Days', 'timeFrame': 'Day 0 to Day 84', 'description': 'Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).'}, {'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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'Pseudomonas aeruginosa', 'Pulmonary Cystic Fibrosis'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '19447923', 'type': 'DERIVED', 'citation': 'Quittner AL, Modi AC, Wainwright C, Otto K, Kirihara J, Montgomery AB. Determination of the minimal clinically important difference scores for the Cystic Fibrosis Questionnaire-Revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. Chest. 2009 Jun;135(6):1610-1618. doi: 10.1378/chest.08-1190. Epub 2009 May 15.'}, {'pmid': '18658109', 'type': 'DERIVED', 'citation': 'McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine for chronic airway Pseudomonas aeruginosa in cystic fibrosis. Am J Respir Crit Care Med. 2008 Nov 1;178(9):921-8. doi: 10.1164/rccm.200712-1804OC. Epub 2008 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).', 'detailedDescription': 'Patients with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called 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 aztreonam for inhalation solution (AZLI), an investigational formulation of the antibiotic administered using the eFlow® Electronic Nebulizer by PARI GmbH, in CF patients with PA.\n\nIn this study, participants were screened for eligibility at Visit 1 (Day -42) and returned to the center for Visit 2 after a 14-day evaluation period. At Visit 2 (Day -28), participants began a 28-day course of open-label Tobramycin Inhalation Solution (TIS). At Visit 3 (Day 0), following completion of the 28-day course of TIS, participants began randomized, blinded treatment with either AZLI twice a day (BID) or three times a day (TID) or placebo BID or TID, and continued treatment for a total of 28 days, with a clinic visit at Day 14 (Visit 4) and at the end of treatment (Visit 5 \\[Day 28\\]). Participants returned for visits every 2 weeks for 8 weeks after the end of the blinded treatment (Visits 6 to 9 \\[Days 42 to 84\\]).\n\nTwo hundred and forty-seven participants were treated in the TIS phase of this study. Two hundred and eleven subjects completed the TIS phase and were treated in the placebo-controlled phase with study drug (AZLI or placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CF as diagnosed by:\n\n 1. Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test; or\n 2. Two well-characterized genetic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or\n 3. Abnormal nasal potential difference with accompanying symptoms characteristic of CF.\n* PA present in expectorated sputum or throat swab culture at Screening.\n* Participants must have received three or more courses of TIS within the previous 12 months.\n* Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin.\n* Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted 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\nExclusion Criteria:\n\n* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day.\n* History of sputum or throat culture swab yielding Burkholderia cepacia in the past 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 device within 28 days of Screening (Visit 1) or within 6 half-lives of the investigational drug (whichever was longer).\n* Known local or systemic hypersensitivity to monobactam antibiotics.\n* Inability to tolerate inhalation of a short acting Beta-2 agonist.\n* Changes in antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days before Screening or between Screening and the next visit.\n* Changes in physiotherapy technique or schedule within 7 days before 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 or serum chemistry at Screening (aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\] greater than 5 times the upper limit of normal range; Creatinine greater than 2 times the upper limit of normal range).\n* Positive pregnancy test at Screening.\n* Female of childbearing potential who was lactating or in the opinion of the investigator was not practicing acceptable birth control.\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.'}, 'identificationModule': {'nctId': 'NCT00104520', 'acronym': 'AIR-CF2', 'briefTitle': '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, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)', 'orgStudyIdInfo': {'id': 'CP-AI-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (pooled two times a day [BID]/three times a day [TID])', 'interventionNames': ['Drug: Placebo two times a day (BID)/three times a day (TID)']}, {'type': 'EXPERIMENTAL', 'label': 'AZLI (pooled two times a day [BID]/three times a day [TID])', 'interventionNames': ['Drug: AZLI 75 mg two times a day (BID)/three times a day (TID)']}], 'interventions': [{'name': 'AZLI 75 mg two times a day (BID)/three times a day (TID)', 'type': 'DRUG', 'armGroupLabels': ['AZLI (pooled two times a day [BID]/three times a day [TID])']}, {'name': 'Placebo two times a day (BID)/three times a day (TID)', 'type': 'DRUG', 'armGroupLabels': ['Placebo (pooled two times a day [BID]/three times a day [TID])']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 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