Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 7:33 AM
Study NCT ID:
NCT01180634
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2010-08-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinformation@horizontherapeutics.com', 'phone': '1-866-479-6742', 'title': 'Medical Monitor', 'organization': 'Horizon Pharma USA, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study until end of study (Up to 59 days)', 'description': 'Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 207, 'seriousNumAtRisk': 219, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 106, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Increased viscosity of bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Increased viscosity of bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 42}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to an Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'comment': 'Upper bound of 95% CI was not estimable due to low number of events', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': 'NA'}, {'value': '51.5', 'comment': 'Upper bound of 95% CI was not estimable due to low number of events', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0715', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.84', 'pValueComment': 'P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'estimateComment': 'Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of study (up to 59 days)', 'description': 'The start of the exacerbation was determined by the earliest date at which a participant concurrently met at least 4 of the 12 modified Fuchs symptoms/signs; discontinued from the study early; died; or received an antipseudomonal agent for an event that did not meet modified Fuchs criteria but was determined to be an exacerbation by the Blinded Exacerbation.\n\nFuchs symptoms/signs;\n\n* Change in sputum\n* New or increased hemoptysis\n* Increased cough\n* Increased dyspnea\n* Malaise, fatigue or lethargy\n* Temperature above 38oC\n* Anorexia or weight loss\n* Sinus pain or tenderness\n* Change in sinus discharge\n* Change in physical examination of the chest\n* Decrease in pulmonary function by 10 percent or more from a previously recorded value\n* Radiographic changes indicative of pulmonary infection\n\nMedian and 95%Ci were estimated using Kaplan Meier estimates.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (IIT) population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.638', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.531', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.21', 'ciUpperLimit': '2.60', 'estimateComment': 'Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'statisticalMethod': 'Repeared Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, day 28', 'description': 'FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'unitOfMeasure': 'Percent Predicted FEV1', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pseudomonas Aeruginosa Sputum Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.139', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '-0.30', 'estimateComment': 'Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), baseline FEV1 (\\<55%, \\>=55%), and baseline organism log density.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Pseudomonas aeruginosa density was measured as log10 colony-forming units \\[CFU\\] per gram sputum. LSMean and standard are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), baseline FEV1 (\\<55%, \\>=55%), and baseline organism log density.', 'unitOfMeasure': 'log10 CFU/g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.66', 'spread': '1.374', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '1.118', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8335', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '2.85', 'estimateComment': 'Estimates were determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12 to 18 years, \\> 18 years), Baseline FEV1 (\\<55%, ≥ 55%), and Baseline value.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'The Cystic Fibrosis Questionnaire (CFQ-R) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. LSMean and standard error were determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12 to 18 years, \\> 18 years), Baseline FEV1 (\\<55%, ≥ 55%), and Baseline value.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data at specified time point.'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline in Percent Predicted FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.24', 'spread': '1.041', 'groupId': 'OG000'}, {'value': '3.66', 'spread': '0.866', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0122', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.42', 'ciLowerLimit': '0.53', 'ciUpperLimit': '4.31', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'unitOfMeasure': 'Percent Predicted FEV1', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with available data at specific timepoint.'}, {'type': 'SECONDARY', 'title': 'Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '60'}, {'value': '55', 'comment': 'Upper bound of 95% CI was not estimable due to low number of events', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.12', 'pValueComment': 'P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'estimateComment': 'Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of study (up to 59 days)', 'description': 'Participants who had at least one of four worsening respiratory symptoms (increased cough, increased sputum/chest congestion, decreased exercise tolerance, decreased appetite) at the time of administration of the anti-pseudomonal antimicrobial agent were included in the analysis. Median and 95% CI are estimated using Kaplan Meier estimates.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Time to First Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper bound of confidence interval were not estimable due to low number of events.', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, lower and upper bound of confidence interval were not estimable due to low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.8670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.47', 'ciUpperLimit': '2.04', 'pValueComment': 'P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'estimateComment': 'Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to end of study (up to 59 days)', 'description': 'Median and 95%CI was estimated using Kaplan Meier estimates.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study until end of study (Up to 59 days)', 'description': 'An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug.\n\nAn AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to:\n\n* Any symptom not previously reported by the patient (medical history)\n* An exacerbation of a pre-existing illness\n* An increase in frequency or intensity of a pre-existing episodic event or condition\n* A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study\n* Overdose of Study Drug', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants in the study who received at least 1 dose of study drug or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aeroquin 240 mg', 'description': 'Participants received 240 mg of Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '10.34', 'groupId': 'BG000'}, {'value': '28.8', 'spread': '10.94', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '10.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2018-01-17', 'completionDateStruct': {'date': '2012-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2010-08-10', 'dispFirstSubmitQcDate': '2018-01-17', 'resultsFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2010-08-10', 'dispFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-29', 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to an Exacerbation', 'timeFrame': 'Baseline to end of study (up to 59 days)', 'description': 'The start of the exacerbation was determined by the earliest date at which a participant concurrently met at least 4 of the 12 modified Fuchs symptoms/signs; discontinued from the study early; died; or received an antipseudomonal agent for an event that did not meet modified Fuchs criteria but was determined to be an exacerbation by the Blinded Exacerbation.\n\nFuchs symptoms/signs;\n\n* Change in sputum\n* New or increased hemoptysis\n* Increased cough\n* Increased dyspnea\n* Malaise, fatigue or lethargy\n* Temperature above 38oC\n* Anorexia or weight loss\n* Sinus pain or tenderness\n* Change in sinus discharge\n* Change in physical examination of the chest\n* Decrease in pulmonary function by 10 percent or more from a previously recorded value\n* Radiographic changes indicative of pulmonary infection\n\nMedian and 95%Ci were estimated using Kaplan Meier estimates.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline, day 28', 'description': 'FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).'}, {'measure': 'Change From Baseline in Pseudomonas Aeruginosa Sputum Density', 'timeFrame': 'Baseline, Day 28', 'description': 'Pseudomonas aeruginosa density was measured as log10 colony-forming units \\[CFU\\] per gram sputum. LSMean and standard are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), baseline FEV1 (\\<55%, \\>=55%), and baseline organism log density.'}, {'measure': 'Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)', 'timeFrame': 'Baseline, Day 28', 'description': 'The Cystic Fibrosis Questionnaire (CFQ-R) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. LSMean and standard error were determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12 to 18 years, \\> 18 years), Baseline FEV1 (\\<55%, ≥ 55%), and Baseline value.'}, {'measure': 'Relative Change From Baseline in Percent Predicted FEV1', 'timeFrame': 'Baseline, Day 28', 'description': 'FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\\*visit, region (US, non-US), age (12-18 years, \\>18 years), and baseline FEV1 (\\<55%, \\>=55%).'}, {'measure': 'Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials', 'timeFrame': 'Baseline to end of study (up to 59 days)', 'description': 'Participants who had at least one of four worsening respiratory symptoms (increased cough, increased sputum/chest congestion, decreased exercise tolerance, decreased appetite) at the time of administration of the anti-pseudomonal antimicrobial agent were included in the analysis. Median and 95% CI are estimated using Kaplan Meier estimates.'}, {'measure': 'Time to First Hospitalization', 'timeFrame': 'Baseline to end of study (up to 59 days)', 'description': 'Median and 95%CI was estimated using Kaplan Meier estimates.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'From start of study until end of study (Up to 59 days)', 'description': 'An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug.\n\nAn AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to:\n\n* Any symptom not previously reported by the patient (medical history)\n* An exacerbation of a pre-existing illness\n* An increase in frequency or intensity of a pre-existing episodic event or condition\n* A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study\n* Overdose of Study Drug'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.', 'detailedDescription': 'This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.\n\nStudy with completed results acquired from Horizon in 2024.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (selected):\n\n* \\>/= 12 years of age\n* Confirmed Diagnosis of Cystic Fibrosis\n* Positive sputum culture for P. aeruginosa at screening and within the past 12 months\n* Patients are able to elicit an FEV1 \\>/= 25% but \\</= 85% of predicted value at screening\n* Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months\n* Clinically stable with no changes in health status within the last 28 days\n* Able to reproducibly produce sputum and perform spirometry\n\nExclusion Criteria (selected):\n\n* Use of any nebulized or systemic antibiotics within 28 days prior to baseline\n* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication\n* Evidence of respiratory infections within 14 days prior to dosing\n* CrCl \\< 20ml/min or \\< 20ml/min/1.73 m2 at Screening'}, 'identificationModule': {'nctId': 'NCT01180634', 'briefTitle': 'MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients', 'orgStudyIdInfo': {'id': 'Mpex-207'}, 'secondaryIdInfos': [{'id': '2010-019515-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aeroquin 240 mg', 'description': 'Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days.', 'interventionNames': ['Drug: Aeroquin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aeroquin', 'type': 'DRUG', 'otherNames': ['MP-376, Levofloxacin Inhalation solution 240 mg'], 'description': 'Inhalation Solution', 'armGroupLabels': ['Aeroquin 240 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inhalation Solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 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