Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-02 @ 12:58 PM
Study NCT ID:
NCT03181932
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2017-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}}}}, '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': 'ray.pratt@savarapharma.com', 'phone': '+1 512 784 8757', 'title': 'Raymond D Pratt, Chief Medical Officer', 'organization': 'Savara Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A total of 200 participants were to be randomized. Consequent to the outbreak of COVID-19, the recruitment was stopped prematurely when 188 participants had been randomized.\n\nThe CFQ-R and CFRSD-CRISS were administered every two weeks using a hand-held e-Diary. The e-Diary had not been activated at the baseline visit for 39 participants. For these participants, missing baseline measurements were imputed with the population median baseline value for inferential analyses.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (AEs) were assessed on or after the first dose of trial drug to 28 days after last dose. For all safety analyses, a single set of results was produced including all participants (6-21 and >21 years combined). For the double-blind Period 1, AE data are presented for the vancomycin and placebo groups whereas for the open-label Period 2, AE data for only one combined group is presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 participants ≤21 years old, 25 participants \\>21 years old) for 24 weeks during Period 1.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 85, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 participants ≤21 years old, 25 participants \\>21 years old) for 24 weeks during Period 1.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 93, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 35}, {'id': 'EG002', 'title': 'Open-label Vancomycin Inhalation Powder', 'description': 'In the 24-week Period 2, all participants receive vancomycin inhalation powder 30 mg BID by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: In the 24-week Period 2, all participants are to be treated with open-label vancomycin inhalation powder.', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 139, 'seriousNumAtRisk': 158, 'deathsNumAffected': 0, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 109, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 116, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 140, 'numAffected': 78}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 62, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 53, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 50, 'numAffected': 40}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 43, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peritoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Systemic viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Distal intestinal obstruction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystic fibrosis related diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Testicular torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mycobacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.39', 'spread': '8.078', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '8.581', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.52', 'spread': '8.414', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '8.056', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '1.61', 'spread': '9.967', 'groupId': 'OG000'}, {'value': '-1.94', 'spread': '8.924', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '4.1', 'groupDescription': 'Based on previous experience, a sample size of 45 participants per arm would provide 89% power to detect a statistically significant difference at alpha level of 0.05. To account for potential dropouts and/or smaller effect size in a 3-cycle trial, a sample size of 75 participants per arm was to be enrolled in the primary analysis population, which if all completed would provide 90% power to detect a difference of 3.4% at 20 weeks assuming the same standard deviation of 6.3%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The primary efficacy endpoint was tested sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3). If a statistically significant difference was observed in favor of vancomycin inhalation powder compared to placebo after Cycle 1, then the mean change in the FEV1 percent predicted during Cycle 2 was to be tested. Similarly, if the effect after Cycle 2 was statistically significant, then the analysis of Baseline to end of Cycle 3 was to be tested.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4, 12 and 20', 'description': 'The mean absolute change from baseline in FEV1 percent predicted was analyzed sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3).', 'unitOfMeasure': 'Percent predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population (defined as all randomized participants). Participants were analyzed according to randomized treatment. The ITT population was also split out by age (≤21 years, \\>21 years). The population of participants ≤21 years was used for all main analyses of efficacy endpoints.'}, {'type': 'SECONDARY', 'title': 'Frequency of Pulmonary Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 20', 'description': 'The number of pulmonary exacerbations during Period 1 adjusted for the length of follow-up.', 'unitOfMeasure': 'exacerbations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (6-21 years).'}, {'type': 'SECONDARY', 'title': 'Time to First Pulmonary Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 20', 'description': 'Time to first pulmonary exacerbation requiring use of another antibiotic medication (oral, IV, and/or inhaled). The Outcome Measure Data presented are the median percentiles and 95% confidence intervals from Kaplan-Meier estimates.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (6-21 years).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '12.7'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '10.6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '8.9'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '10.1'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '11.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4, 12, and 20', 'description': 'The CFQ-R was administered every two weeks using a hand-held e-Diary. CFQ-R scores range between 0 and 100, where higher scores indicate a better outcome. The CFQ-R measures functioning in a variety of domains, including Physical Functioning, Vitality, Health Perceptions, Respiratory Symptoms, Treatment Burden, Role Functioning, Emotional Functioning and Social Functioning. The Outcome Measure Data presented are the Respiratory Symptoms Scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (6-21 years).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cystic Fibrosis Respiratory Symptom Diary-Chronic Respiratory Symptom Score (CFRSD-CRISS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-7.3', 'upperLimit': '0.9'}, {'value': '-5.1', 'groupId': 'OG001', 'lowerLimit': '-9.1', 'upperLimit': '-1.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-4.7', 'groupId': 'OG000', 'lowerLimit': '-10.1', 'upperLimit': '0.6'}, {'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-13.3', 'upperLimit': '-2.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-7.3', 'groupId': 'OG000', 'lowerLimit': '-12.5', 'upperLimit': '-2.0'}, {'value': '-5.3', 'groupId': 'OG001', 'lowerLimit': '-10.3', 'upperLimit': '-0.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4, 12 and 20', 'description': 'The CFRSD-CRISS was administered every two weeks using a hand-held e-Diary. Scores range between 0 and 100, where higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (6-21 years).'}, {'type': 'SECONDARY', 'title': 'Relative Change in FEV1 Percent Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '6.8'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '5.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '5.2'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '3.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '6.1'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-6.4', 'upperLimit': '2.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4, 12 and 20', 'description': 'The mean relative change from Baseline in FEV1 percent predicted', 'unitOfMeasure': 'percent predicted', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (6-21 years).'}, {'type': 'SECONDARY', 'title': 'Number of Successful Response Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'categories': [{'title': '0 successful response cycles', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': '1 successful response cycle', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': '2 successful response cycles', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': '3 successful response cycles', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 20', 'description': 'The number of successful response cycles a participant achieves over Period 1. A response in a cycle is defined by at least a 5 % relative improvement in FEV1 percent predicted at the end of each the respective cycle.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (6-21 years).'}, {'type': 'SECONDARY', 'title': 'Area Under the FEV1-time Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'OG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '609.7', 'groupId': 'OG000', 'lowerLimit': '520.8', 'upperLimit': '698.7'}, {'value': '583.1', 'groupId': 'OG001', 'lowerLimit': '499.8', 'upperLimit': '666.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 20', 'description': 'The mean treatment difference in FEV1 across all post-baseline visits', 'unitOfMeasure': 'percent predicted*hour/liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (6-21 years).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'FG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}], 'periods': [{'title': 'Period 1 (Double-blind Period)', 'milestones': [{'type': 'STARTED', 'comment': 'The number of started participants include both age groups (participants 6-21 years and \\>21 years). The primary efficacy population was the 6-21 years age group. All Outcome Results are presented for the primary age group. The Baseline Characteristics and Safety Results are presented for all participants.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': 'Period 2 (Open-label Period)', 'milestones': [{'type': 'STARTED', 'comment': 'The numbers refer to the treatment that the participants received during Period 1. 6 participants (4 in the vancomycin group and 2 in the placebo group) who completed Period 1 decided not to participate in Period 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Reason missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '76 sites in Canada (2 clinics) and US (74 clinics) enrolled participants in the trial. First participant was enrolled on 20 September 2017 and last subject completed the study on 15 January 2021.', 'preAssignmentDetails': 'A total of 353 participants were screened, and 188 were randomized in Period 1. In total, 165 participants were screen failures and the reasons for screen failure were ineligibility (n=157), exacerbation (n=6), lost to follow-up (n=1) and other reason (n=1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind Vancomycin Inhalation Powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nVancomycin inhalation powder: 100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'BG001', 'title': 'Double-blind Placebo Inhalation Powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.\n\nPlacebo inhalation powder: 100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '12.52', 'groupId': 'BG000'}, {'value': '18.2', 'spread': '8.70', 'groupId': 'BG001'}, {'value': '19.2', 'spread': '10.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '6-21 years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': '>21 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '178', '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': '0', 'groupId': 'BG000'}, {'value': '1', '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': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}, {'title': 'Pseudomonas Aeruginosa Infection Present at Screening (Yes/No?)', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Pulmonary Infections in the Previous Year', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.53', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '1.44', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'infections', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted', 'classes': [{'categories': [{'measurements': [{'value': '65.25', 'spread': '16.193', 'groupId': 'BG000'}, {'value': '66.32', 'spread': '16.939', 'groupId': 'BG001'}, {'value': '65.81', 'spread': '16.550', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent predicted', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The number of baseline participants include both age groups (participants 6-21 years and \\>21 years).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-18', 'size': 14026246, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-10T13:03', 'hasProtocol': True}, {'date': '2020-11-05', 'size': 2018460, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-10T13:03', 'hasProtocol': False}]}}, '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': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2017-06-01', 'resultsFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-10', 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted', 'timeFrame': 'Baseline and Week 4, 12 and 20', 'description': 'The mean absolute change from baseline in FEV1 percent predicted was analyzed sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3).'}], 'secondaryOutcomes': [{'measure': 'Frequency of Pulmonary Exacerbations', 'timeFrame': 'Week 20', 'description': 'The number of pulmonary exacerbations during Period 1 adjusted for the length of follow-up.'}, {'measure': 'Time to First Pulmonary Exacerbation', 'timeFrame': 'Week 20', 'description': 'Time to first pulmonary exacerbation requiring use of another antibiotic medication (oral, IV, and/or inhaled). The Outcome Measure Data presented are the median percentiles and 95% confidence intervals from Kaplan-Meier estimates.'}, {'measure': 'Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Scores', 'timeFrame': 'Baseline and Week 4, 12, and 20', 'description': 'The CFQ-R was administered every two weeks using a hand-held e-Diary. CFQ-R scores range between 0 and 100, where higher scores indicate a better outcome. The CFQ-R measures functioning in a variety of domains, including Physical Functioning, Vitality, Health Perceptions, Respiratory Symptoms, Treatment Burden, Role Functioning, Emotional Functioning and Social Functioning. The Outcome Measure Data presented are the Respiratory Symptoms Scores.'}, {'measure': 'Change From Baseline in Cystic Fibrosis Respiratory Symptom Diary-Chronic Respiratory Symptom Score (CFRSD-CRISS) Scores', 'timeFrame': 'Baseline and Week 4, 12 and 20', 'description': 'The CFRSD-CRISS was administered every two weeks using a hand-held e-Diary. Scores range between 0 and 100, where higher scores indicate a worse outcome.'}, {'measure': 'Relative Change in FEV1 Percent Predicted', 'timeFrame': 'Baseline and Week 4, 12 and 20', 'description': 'The mean relative change from Baseline in FEV1 percent predicted'}, {'measure': 'Number of Successful Response Cycles', 'timeFrame': 'Week 20', 'description': 'The number of successful response cycles a participant achieves over Period 1. A response in a cycle is defined by at least a 5 % relative improvement in FEV1 percent predicted at the end of each the respective cycle.'}, {'measure': 'Area Under the FEV1-time Profile', 'timeFrame': 'Week 20', 'description': 'The mean treatment difference in FEV1 across all post-baseline visits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MRSA', 'Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '36511181', 'type': 'DERIVED', 'citation': 'Lo DK, Muhlebach MS, Smyth AR. Interventions for the eradication of meticillin-resistant Staphylococcus aureus (MRSA) in people with cystic fibrosis. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD009650. doi: 10.1002/14651858.CD009650.pub5.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).', 'detailedDescription': 'This is a phase III, randomized, multicenter, double-blind, placebo-controlled, parallel-group study to examine the safety and efficacy of AeroVanc in the treatment of persistent MRSA lung infection in patients diagnosed with CF. After the Screening period to confirm study eligibility, participants are randomly assigned in a blinded fashion to receive either AeroVanc 30 mg twice daily (BID), or placebo BID (1:1 active to placebo) by inhalation for 24 weeks or 3 dosing cycles (Period 1). Upon completion of Period 1, participants receive open-label AeroVanc 30 mg BID for an additional 24 weeks or 3 dosing cycles (Period 2), to evaluate long-term safety of AeroVanc. A dosing cycle is defined as 28 days of treatment followed by 28 days of observation.\n\nParticipants on a 28-day cyclical on/off anti-Pseudomonal antibiotic regimen enter the Screening period at a time such that the Baseline visit coincide with the end of their anti-Pseudomonas antibiotic cycle. Study drug is thereby administered during the off-cycle, and participants can then resume anti-Pseudomonal therapy during the 28-day observation period. Participants continuing alternating anti-Pseudomonal therapy can continue their treatment during the study drug administration, and observation period.\n\nThe primary and secondary analyses are conducted in participants ≤21 years old. Subjects \\>21 years old are analyzed separately as supportive analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Participants ≥6 years of age at time of informed consent form or assent form signing.\n2. Confirmed diagnosis of CF, determined by having clinical features consistent with the CF phenotype, plus one of the following:\n\n 1. Positive sweat chloride test (value ≥60 milliequivalent/L),\n 2. Genotype with 2 mutations consistent with CF (i.e., a mutation in each of the cystic fibrosis transmembrane conductance regulator genes).\n3. Positive sputum culture or a throat swab culture for MRSA at Screening.\n4. In addition to the Screening sample, have at least 2 prior sputum or throat swab cultures positive for MRSA, of which at least 1 sample is \\>6 months prior to Screening. At least 50% of all MRSA cultures (sputum or throat swab culture) collected from the time of the first positive culture (in the previous 1 year) must have tested positive for MRSA. (Note: Screening sample may count towards 50% positive count)\n5. FEV1 ≥30% and ≤90% of predicted that is normal for age, gender, race, and height, using the Global Lung Function Initiative equation.\n6. At least 1 episode of acute pulmonary infection treated with non-maintenance antibiotics within 12 months prior to the Baseline visit (initiation of treatment with intermittent inhaled anti-Pseudomonal therapy will not qualify as treatment with non-maintenance antibiotics).\n7. If female of childbearing potential, an acceptable method of contraception must be used during the study and must be combined with a negative pregnancy test obtained during Screening; sexually active male subjects of reproductive potential who are non-sterile (i.e., male who has not been sterilized by vasectomy for at least 6 months, and were not diagnosed with infertility through demonstration of azoospermia in a semen sample and/or absence of vas deferens through ultrasound) must be willing to use a barrier method of contraception, or their female partner must use an acceptable method of contraception, during the study.\n\n For purposes of this study, the Sponsor defines "acceptable methods of contraception" as:\n 1. Oral birth control pills administered for at least 1 monthly cycle prior to administration of the study drug.\n 2. A synthetic progestin implanted rod (eg, Implanon®) for at least 1 monthly cycle prior to the study drug administration but not beyond the 4th successive year following insertion.\n 3. Intrauterine devices, inserted by a qualified clinician for at least 1 monthly cycle prior to study drug administration.\n 4. Medroxyprogesterone acetate (eg, Depo-Provera®) administered for a minimum of 1 monthly cycle prior to administration of the study drug and continuing through 1 month following study completion.\n 5. Hysterectomy or surgical sterilization.\n 6. Abstinence.\n 7. Double barrier method (diaphragm with spermicidal gel or condoms with contraceptive foam).\n\n Note: For subjects prescribed Orkambi: Orkambi may substantially decrease hormonal contraceptive exposure, reducing the effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi.\n8. Able and willing to comply with the protocol, including availability for all scheduled study visits and able to perform all techniques necessary to use the AeroVanc inhaler and measure lung function.\n9. Agree not to smoke during any part of the clinical trial (Screening visit through end of study).\n10. Participants with a Pseudomonas aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the Investigator, stable despite the lack of such treatment.\n\nExclusion criteria\n\n1. Use of anti-MRSA treatments prescribed as maintenance therapy (intravenous \\[IV\\] or inhaled treatment within 28 days; oral treatment within 14 days) prior to the Baseline visit.\n2. Use of non-maintenance antibiotic for pulmonary infection or extrapulmonary MRSA infection (IV or inhaled antibiotic within 28 days; oral antibiotic within 14 days) prior to the Baseline visit.\n3. History of previous allergies or sensitivity to vancomycin, or other component(s) of the study drug or placebo except for a history of red-man syndrome.\n4. Inability to tolerate inhaled products.\n5. First time sputum culture or throat swab culture yielding Burkholderia cepacia, or nontuberculous Mycobacteria in the previous 6 months to Screening.\n6. History of lung or other solid organ transplantation or currently on the list to receive lung or other solid organ transplantation.\n7. Resistance to vancomycin at Screening (vancomycin resistant Staphylococcus aureus, or vancomycin intermediate resistant Staphylococcus aureus, with minimum inhibitory concentration ≥8 μg/mL).\n8. Oral corticosteroids in doses exceeding 10 mg prednisone per day or 20 mg prednisone every other day, or equipotent doses of other corticosteroids.\n9. Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 14 days, or changes in cystic fibrosis transmembrane conductance modulators within 28 days, prior to the Baseline visit.\n10. Abnormal laboratory findings or other findings or medical history at Screening that, in the Investigator\'s opinion, would compromise the safety of the subject or the quality of the study data.\n11. Inability to tolerate inhalation of a short acting beta2 agonist\n12. Oxygen saturation \\<90% at Screening.\n13. Changes in physiotherapy technique or physiotherapy scheduled within 1 week of the Baseline visit.\n14. Administration of any investigational drug or device within 4 weeks prior to the Screening visit and during the study\n15. Female with positive pregnancy test result during Screening, pregnant (or intends to become pregnant), lactating or intends to breastfeed during the study.\n16. Renal insufficiency, defined as creatinine clearance \\<50 mL/min using the Cockcroft-Gault equation for adults or Schwartz equation for children at the Screening visit.\n17. Abnormal liver function, defined as ≥4x upper limit of normal of serum aspartate aminotransferase or serum alanine aminotransferase, or known cirrhosis at Screening.\n18. Diagnosed with clinically significant hearing loss.\n19. History of positive result for human immunodeficiency virus, hepatitis B virus or hepatitis C virus.\n20. Planned hospitalizations for prophylaxis antibiotic treatment within 28 days prior to Baseline visit or during the double-blind period (Period 1).'}, 'identificationModule': {'nctId': 'NCT03181932', 'briefTitle': 'AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Savara Inc.'}, 'officialTitle': 'A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients', 'orgStudyIdInfo': {'id': 'SAV005-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double-blind vancomycin inhalation powder', 'description': 'Vancomycin inhalation powder 30 mg is administered twice daily (BID) during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.', 'interventionNames': ['Drug: Vancomycin inhalation powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-blind placebo inhalation powder', 'description': 'Matching placebo is administered BID during the 24-week double-blind period (Period 1) by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.', 'interventionNames': ['Drug: Placebo inhalation powder']}, {'type': 'EXPERIMENTAL', 'label': 'Open-label vancomycin inhalation powder', 'description': 'In the 24-week Period 2, all participants receive AeroVanc 30 mg BID by inhalation during three dosing cycles, each cycle being 28 days of treatment followed by 28 days of observation.', 'interventionNames': ['Drug: Vancomycin inhalation powder']}], 'interventions': [{'name': 'Vancomycin inhalation powder', 'type': 'DRUG', 'otherNames': ['AeroVanc'], 'description': '100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.', 'armGroupLabels': ['Double-blind vancomycin inhalation powder']}, {'name': 'Placebo inhalation powder', 'type': 'DRUG', 'description': '100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects \\>21 years old) for 24 weeks during Period 1.', 'armGroupLabels': ['Double-blind placebo inhalation powder']}, {'name': 'Vancomycin inhalation powder', 'type': 'DRUG', 'otherNames': ['AeroVanc'], 'description': 'In the 24-week Period 2, all participants are to be treated with open-label vancomycin inhalation powder.', 'armGroupLabels': ['Open-label vancomycin inhalation powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pulmonary Associates of Mobile', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Miller Childrens Hospital MemorialCare Health System Pediatric Pulmonology', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Keck Medical Center of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 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