Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-19 @ 5:54 AM
Study NCT ID:
NCT01253603
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2010-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Pharmacokinetics of QAW039
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604875', 'term': 'fevipiprant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2013-10-29', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2010-12-01', 'dispFirstSubmitQcDate': '2013-10-29', 'studyFirstSubmitQcDate': '2010-12-01', 'dispFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.', 'timeFrame': '28 days'}]}, 'conditionsModule': {'keywords': ['Asthma'], 'conditions': ['Persistent Asthma']}, 'referencesModule': {'references': [{'pmid': '27354118', 'type': 'DERIVED', 'citation': 'Erpenbeck VJ, Popov TA, Miller D, Weinstein SF, Spector S, Magnusson B, Osuntokun W, Goldsmith P, Weiss M, Beier J. The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma. Pulm Pharmacol Ther. 2016 Aug;39:54-63. doi: 10.1016/j.pupt.2016.06.005. Epub 2016 Jun 21.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10283', 'label': 'Results for CQAW039A2201 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a medical history of mild to moderate persistent allergic asthma.\n* Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \\>17 kg/m2.\n* Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception\n\nExclusion Criteria:\n\n* Women of child-bearing potential.\n* Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year\n* Patients with severe persistent asthma\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01253603', 'briefTitle': 'Efficacy, Safety, and Pharmacokinetics of QAW039', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma', 'orgStudyIdInfo': {'id': 'CQAW039A2201'}, 'secondaryIdInfos': [{'id': '2010-020177-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'QAW039 capsules once daily for 28 days', 'interventionNames': ['Drug: QAW039 capsules once daily for 28 days']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Placebo to QAW039 capsules once daily for 28 days', 'interventionNames': ['Drug: Placebo to QAW039 capsules once daily for 28 days']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Fluticasone propionate inhaler twice daily for 28 days', 'interventionNames': ['Drug: Fluticasone propionate inhaler twice daily for 28 days']}], 'interventions': [{'name': 'QAW039 capsules once daily for 28 days', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Placebo to QAW039 capsules once daily for 28 days', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Fluticasone propionate inhaler twice daily for 28 days', 'type': 'DRUG', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92647', 'city': 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'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Jambes', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.45636, 'lon': 4.87166}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 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