Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT01404234
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2011-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001398', 'term': 'Aztreonam'}], 'ancestors': [{'id': 'D008997', 'term': 'Monobactams'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Day 168', 'eventGroups': [{'id': 'EG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.', 'otherNumAtRisk': 61, 'otherNumAffected': 50, 'seriousNumAtRisk': 61, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Appendiceal mucocoele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 168', 'description': 'Participants who discontinued study drug due to safety or tolerability reasons were defined as those with "Adverse Event (AE)/Safety or Tolerability" on the Study Drug Completion electronic case report form as the reason for early discontinuation. The 95% confidence interval (CI) was calculated using the exact binomial method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (enrolled and received at least 1 dose of study medication) who completed the study or discontinued study drug due to safety or tolerability reasons were analyzed. Two participants voluntarily withdrew from the study prior to completion (not due to AEs/safety or tolerability reasons).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1 % Predicted in Subjects Aged ≥ 6 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'title': 'Change at Day 28 (on-treatment, n = 52)', 'categories': [{'measurements': [{'value': '4.73', 'spread': '11.703', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84 (on-treatment, n = 51)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '12.516', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 140 (on-treatment, n = 50)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '10.340', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28, 84, and 140', 'description': 'The change in FEV1 % predicted was assessed at the end of each 28-day AZLI treatment course.\n\nFEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition.', 'unitOfMeasure': 'percentage of FEV1 % predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set ≥ 6 years of age were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CFQ-R Respiratory Symptoms Scale (RSS) Score in Subjects Aged ≥ 6 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'title': 'Change at Day 28 (on-treatment, n = 51)', 'categories': [{'measurements': [{'value': '8.66', 'spread': '14.903', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84 (on-treatment, n = 48)', 'categories': [{'measurements': [{'value': '9.38', 'spread': '18.243', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 140 (on-treatment, n = 48)', 'categories': [{'measurements': [{'value': '5.90', 'spread': '15.372', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28, 84, and 140', 'description': 'The change in CFQ-R RSS score was assessed at the end of each 28-day AZLI treatment course.\n\nThe range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set ≥ 6 years of age were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Pseudomonas Aeruginosa (PA) Sputum Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'title': 'Change at Day 28 (on-treatment, n = 24)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 84 (on-treatment, n = 25)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'Change at Day 140 (on-treatment, n = 23)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28, 84, and 140', 'description': 'The change in PA sputum density (log10 colony-forming units per gram \\[cfu/g\\]) was assessed at the end of each 28-day AZLI treatment course.', 'unitOfMeasure': 'log10 CFU/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set ≥ 6 years of age were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Additional (Non-study) Antipseudomonal Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'title': 'Never used non-study antipseudomonal antibiotics', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}]}]}, {'title': 'Used non-study antipseudomonal antibiotics', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 168', 'description': 'The percentage of participants who used additional (non-study) antipseudomonal antibiotics (IV, inhaled, oral, IV/inhaled, IV/inhaled/oral) was summarized (number and percent) for all subjects.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Hospitalized at Least Once Due to a Respiratory Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'title': 'Never hospitalized', 'categories': [{'measurements': [{'value': '82.0', 'groupId': 'OG000'}]}]}, {'title': 'Hospitalized at least once', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 168', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Days Participants Were Hospitalized Due to a Respiratory Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '8.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 168', 'description': 'The average number of days hospitalized due to a respiratory event, among the 11 participants who were hospitalized for respiratory event, was reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pulmonary Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'title': 'No pulmonary exacerbation', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}]}]}, {'title': 'At least one pulmonary exacerbation', 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 168', 'description': 'Pulmonary exacerbations were defined as respiratory hospitalizations or discrete courses of non-study IV/inhaled antipseudomonal antibiotics. Use of oral antibiotics alone for respiratory signs or symptoms was considered to be representative of milder clinical events and, therefore, was not included in the definition of pulmonary exacerbations.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Time to Pulmonary Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '176.0', 'comment': 'Some participants did not use non-study antipseudomonal antibiotics until the end of the study, so time to non-study antipseudomonal antibiotic use was unknown. Therefore, the upper limit of the 95% CI for median time could not be estimated.', 'groupId': 'OG000', 'lowerLimit': '176.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Day 168', 'description': 'The median days to first pulmonary exacerbation was summarized using Kaplan-Meier (KM) summary statistics.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Study-drug Induced Bronchospasm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '6.06', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pretreatment at Baseline to 30 minutes following treatment', 'description': "Study-drug induced bronchospasm (airway reactivity) was assessed at the baseline visit as the percent change in FEV1 from the pretreatment measurement to 30 minutes following treatment for subjects ≥ 6 years or as from the Investigator's assessment for subjects \\< 6 years.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Adverse Event Rates Adjusted for Study Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'classes': [{'title': 'Cough', 'categories': [{'measurements': [{'value': '0.163', 'groupId': 'OG000'}]}]}, {'title': 'Nasal congestion', 'categories': [{'measurements': [{'value': '0.050', 'groupId': 'OG000'}]}]}, {'title': 'Rhinorrhoea', 'categories': [{'measurements': [{'value': '0.041', 'groupId': 'OG000'}]}]}, {'title': 'Wheezing', 'categories': [{'measurements': [{'value': '0.033', 'groupId': 'OG000'}]}]}, {'title': 'Sputum increased', 'categories': [{'measurements': [{'value': '0.033', 'groupId': 'OG000'}]}]}, {'title': 'Productive Cough', 'categories': [{'measurements': [{'value': '0.030', 'groupId': 'OG000'}]}]}, {'title': 'Lung disorder', 'categories': [{'measurements': [{'value': '0.025', 'groupId': 'OG000'}]}]}, {'title': 'Haemoptysis', 'categories': [{'measurements': [{'value': '0.019', 'groupId': 'OG000'}]}]}, {'title': 'Rhonchi', 'categories': [{'measurements': [{'value': '0.019', 'groupId': 'OG000'}]}]}, {'title': 'Oropharyngeal pain', 'categories': [{'measurements': [{'value': '0.017', 'groupId': 'OG000'}]}]}, {'title': 'Rales', 'categories': [{'measurements': [{'value': '0.017', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory tract congestion', 'categories': [{'measurements': [{'value': '0.014', 'groupId': 'OG000'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '0.030', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '0.019', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0.019', 'groupId': 'OG000'}]}]}, {'title': 'Abdominal pain upper', 'categories': [{'measurements': [{'value': '0.017', 'groupId': 'OG000'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '0.061', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '0.025', 'groupId': 'OG000'}]}]}, {'title': 'Rhinitis', 'categories': [{'measurements': [{'value': '0.030', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary function test decreased', 'categories': [{'measurements': [{'value': '0.014', 'groupId': 'OG000'}]}]}, {'title': 'Forced expiratory volume decreased', 'categories': [{'measurements': [{'value': '0.011', 'groupId': 'OG000'}]}]}, {'title': 'Decreased appetite', 'categories': [{'measurements': [{'value': '0.017', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 168', 'description': 'Adverse events occurring in ≥ 5% of participants adjusted for study duration were summarized. The adjustment was made by using a standardized rate calculated as the sum of study duration across patients divided by 28 for the total number of patient months. Rate calculations presented are the number of adverse events (AEs) per patient month.', 'unitOfMeasure': 'AEs (per patient month)', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of Aztreonam for Inhalation Solution (AZLI), each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at a total of 25 study sites in the United States and Europe. The first participant was screened on 29 December 2011. The last participant observation was on 03 April 2013.', 'preAssignmentDetails': '74 participants were screened; 61 participants were enrolled and treated, and comprise the Safety Analysis Set and the Full Analysis Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '2.94', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 2 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '≥ 2 years to < 6 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '≥ 6 years to ≤ 12 years', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Not Permitted', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '1.66', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced expiratory volume in 1 second (FEV1) % predicted', 'classes': [{'categories': [{'measurements': [{'value': '80.31', 'spread': '19.494', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition. Participants ≥ 6 years of age were analyzed at baseline for FEV1 % predicted (n = 52).', 'unitOfMeasure': 'percentage of FEV1 % predicted', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1', 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '0.627', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FEV1 is defined as the maximal volume of air that can be exhaled in 1 second. Participants ≥ 6 years of age were analyzed at baseline for FEV1 (n = 52).', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced vital capacity (FVC)', 'classes': [{'categories': [{'measurements': [{'value': '2.11', 'spread': '0.687', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FVC is defined as the volume of air that can forcibly be blown out after taking a full breath. Participants ≥ 6 years of age were analyzed at baseline for FVC (n = 52).', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV25-75', 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'spread': '1.169', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC. Participants ≥ 6 years of age were analyzed at baseline for FEV25-75 (n = 52).', 'unitOfMeasure': 'liters/sec', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CFQ-R RSS Score', 'classes': [{'categories': [{'measurements': [{'value': '71.73', 'spread': '17.327', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. Participants ≥ 6 years of age were analyzed at baseline for CFQ-R RSS (n = 51; data was missing for one participant).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Presence of Pseudomonas aeruginosa (PA)', 'classes': [{'title': 'Present', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': 'Absent', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The safety analysis set included all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2011-07-26', 'resultsFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2011-07-27', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-31', 'studyFirstPostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons', 'timeFrame': 'Baseline to Day 168', 'description': 'Participants who discontinued study drug due to safety or tolerability reasons were defined as those with "Adverse Event (AE)/Safety or Tolerability" on the Study Drug Completion electronic case report form as the reason for early discontinuation. The 95% confidence interval (CI) was calculated using the exact binomial method.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FEV1 % Predicted in Subjects Aged ≥ 6 Years', 'timeFrame': 'Baseline to Day 28, 84, and 140', 'description': 'The change in FEV1 % predicted was assessed at the end of each 28-day AZLI treatment course.\n\nFEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition.'}, {'measure': 'Change From Baseline in CFQ-R Respiratory Symptoms Scale (RSS) Score in Subjects Aged ≥ 6 Years', 'timeFrame': 'Baseline to Day 28, 84, and 140', 'description': 'The change in CFQ-R RSS score was assessed at the end of each 28-day AZLI treatment course.\n\nThe range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms.'}, {'measure': 'Change in Pseudomonas Aeruginosa (PA) Sputum Density', 'timeFrame': 'Baseline to Day 28, 84, and 140', 'description': 'The change in PA sputum density (log10 colony-forming units per gram \\[cfu/g\\]) was assessed at the end of each 28-day AZLI treatment course.'}, {'measure': 'Percentage of Participants Who Used Additional (Non-study) Antipseudomonal Antibiotics', 'timeFrame': 'Baseline to Day 168', 'description': 'The percentage of participants who used additional (non-study) antipseudomonal antibiotics (IV, inhaled, oral, IV/inhaled, IV/inhaled/oral) was summarized (number and percent) for all subjects.'}, {'measure': 'Percentage of Participants Hospitalized at Least Once Due to a Respiratory Event', 'timeFrame': 'Baseline to Day 168'}, {'measure': 'Number of Days Participants Were Hospitalized Due to a Respiratory Event', 'timeFrame': 'Baseline to Day 168', 'description': 'The average number of days hospitalized due to a respiratory event, among the 11 participants who were hospitalized for respiratory event, was reported.'}, {'measure': 'Percentage of Participants With Pulmonary Exacerbations', 'timeFrame': 'Baseline to Day 168', 'description': 'Pulmonary exacerbations were defined as respiratory hospitalizations or discrete courses of non-study IV/inhaled antipseudomonal antibiotics. Use of oral antibiotics alone for respiratory signs or symptoms was considered to be representative of milder clinical events and, therefore, was not included in the definition of pulmonary exacerbations.'}, {'measure': 'Time to Pulmonary Exacerbation', 'timeFrame': 'Baseline to Day 168', 'description': 'The median days to first pulmonary exacerbation was summarized using Kaplan-Meier (KM) summary statistics.'}, {'measure': 'Percentage of Participants With Study-drug Induced Bronchospasm', 'timeFrame': 'Pretreatment at Baseline to 30 minutes following treatment', 'description': "Study-drug induced bronchospasm (airway reactivity) was assessed at the baseline visit as the percent change in FEV1 from the pretreatment measurement to 30 minutes following treatment for subjects ≥ 6 years or as from the Investigator's assessment for subjects \\< 6 years."}, {'measure': 'Adverse Event Rates Adjusted for Study Duration', 'timeFrame': 'Baseline to Day 168', 'description': 'Adverse events occurring in ≥ 5% of participants adjusted for study duration were summarized. The adjustment was made by using a standardized rate calculated as the sum of study duration across patients divided by 28 for the total number of patient months. Rate calculations presented are the number of adverse events (AEs) per patient month.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cystic fibrosis', 'CF', 'PA', 'Pseudomonas aeruginosa', 'AZLI', 'aztreonam', 'Chronic Pseudomonas aeruginosa'], 'conditions': ['Cystic Fibrosis', 'Pseudomonas Aeruginosa']}, 'descriptionModule': {'briefSummary': 'This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria:\n\n * Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR\n * Abnormal nasal transepithelial potential difference (NPD) test OR\n * A genotype with 2 identifiable mutations consistent with CF AND\n * One or more clinical features consistent with CF.\n* Documented positive lower respiratory tract culture for PA at the screening visit plus two documented positive lower respiratory tract cultures for PA within 12 months prior to study entry (must have been a minimum 3 months apart.)\n* Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would have required administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.\n\nExclusion Criteria:\n\n* Use of IV or inhaled antipseudomonal antibiotics within 14 days of study entry\n* Presence of a condition or abnormality that would have compromised the participant's safety or the quality of study data, in the opinion of the investigator\n* History of sputum or throat swab culture yielding Burkholderia spp. within 2 years prior to screening visit\n* History of hypersensitivity/adverse reaction to aztreonam\n* History of hypersensitivity/adverse reaction to beta-agonists\n* History of lung transplantation\n* Administration of any investigational drug or device within 30 days prior to screening visit or within 6 half-lives of the investigational drug (whichever was longer)\n* Hospitalization for pulmonary-related illness within 28 days prior to screening visit\n* Changes in or initiation of chronic azithromycin treatment within 28 days prior to screening visit\n* Changes in or initiation of hypertonic saline treatment within 7 days prior to screening visit; for subjects on a stable regimen of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic saline was allowed\n* Changes in antimicrobial, bronchodilator (BD), corticosteroid or dornase alfa medications within 7 days prior to screening visit;\n* Changes in physiotherapy technique or schedule within 7 days prior to screening visit\n* Abnormal renal or hepatic function results at most recent test within the previous 90 days"}, 'identificationModule': {'nctId': 'NCT01404234', 'acronym': 'PALS', 'briefTitle': 'Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways', 'orgStudyIdInfo': {'id': 'GS-US-205-0160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label AZLI', 'description': 'Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment.', 'interventionNames': ['Drug: AZLI']}], 'interventions': [{'name': 'AZLI', 'type': 'DRUG', 'otherNames': ['Cayston®'], 'description': 'AZLI 75 mg was administered 3 times daily via the investigational nebulizer.', 'armGroupLabels': ['Open-label AZLI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital - Denver", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic - Jacksonville", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital & Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'C.H.U de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lisieux', 'country': 'France', 'facility': 'Centre Hospitalier Robert Bissons', 'geoPoint': {'lat': 49.1466, 'lon': 0.22925}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Universitatsklinik St. Josef-Hospital', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Erlandgen', 'country': 'Germany', 'facility': 'Kinder und Jugendklinik, Abteilung Lungen Bronchialheikunde'}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Universitatsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'J.W. Goethe University Hopsital', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria - Policlinico di Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'A. Meyer Children Hospital Florence', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Instituti Ospitalieri di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Rabka-Zdrój', 'country': 'Poland', 'facility': 'Instytut Gruzlicy I Chorob Pluc', 'geoPoint': {'lat': 49.60889, 'lon': 19.96654}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Matki i Dziecka', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Pediatric Pneunmonology and Cystic Fibrosis Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil Universitario Nino Jesus', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hosp. Mat-Inf. Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Mark Bresnik, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}