Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-01 @ 10:52 AM
Study NCT ID:
NCT00506792
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2007-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2012-05-02', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2007-07-22', 'dispFirstSubmitQcDate': '2012-05-02', 'studyFirstSubmitQcDate': '2007-07-23', 'dispFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamic response to single intranasal doses of QAU145 in cystic fibrosis patients using nasal potential difference measurements up to 6 hours post-dose.', 'timeFrame': 'Part I: Baseline, 2 hr post dose, after each dose, end of Part I. Part II: Pre dose and 2 hours post each dose'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of single ascending doses assessed by nasal examinations, adverse events, medications, and a nasal symptom questionnaire. Pharmacokinetics up to 6 hours post-dose', 'timeFrame': 'Part I: Throughout study (about 8 weeks) Part II: Throughout study (about 9 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cystic fibrosis, QAU145, nasal potential difference'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '23412700', 'type': 'DERIVED', 'citation': 'Rowe SM, Reeves G, Hathorne H, Solomon GM, Abbi S, Renard D, Lock R, Zhou P, Danahay H, Clancy JP, Waltz DA. Reduced sodium transport with nasal administration of the prostasin inhibitor camostat in subjects with cystic fibrosis. Chest. 2013 Jul;144(1):200-207. doi: 10.1378/chest.12-2431.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14397', 'label': 'Results for CQAU145A2201 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50.\n\nExclusion Criteria:\n\n* Any presence of seasonal or non-seasonal allergies affecting the nose, nasal passages, throat or sinuses within 2 weeks prior to dosing.\n* Any upper respiratory tract infection or signs or symptoms within 2 weeks prior to dosing.\n* Any presence of nasal polyps or structural abnormalities, frequent history of nose bleeding, or any recent nasal surgery (within 12 weeks prior to dosing).'}, 'identificationModule': {'nctId': 'NCT00506792', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Two-part, Randomized, Double-blind, Placebo-controlled, Ascending Single-dose, Adaptive Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAU145 Administered Via a Nasal Spray Pump to Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'CQAU145A2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'QAU145', 'interventionNames': ['Drug: QAU145']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QAU145', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigative site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}