Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT01495494
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2011-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-20', 'studyFirstSubmitDate': '2011-12-16', 'studyFirstSubmitQcDate': '2011-12-16', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermal response score of the application site of the nasal strip', 'timeFrame': 'Baseline through 7 days'}], 'secondaryOutcomes': [{'measure': 'Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nasal Strip'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '30305980', 'type': 'DERIVED', 'citation': 'Ward J, Ciesla R, Becker W, Shanga GM. Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Allergy Rhinol (Providence). 2018 Oct 5;9:2152656718796740. doi: 10.1177/2152656718796740. eCollection 2018 Jan-Dec.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the safety \\& tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects'}, 'identificationModule': {'nctId': 'NCT01495494', 'briefTitle': 'A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype', 'orgStudyIdInfo': {'id': 'B3560692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Marketed nasal strip', 'description': 'Marketed nasal strip', 'interventionNames': ['Device: Marketed Nasal Strip']}, {'type': 'EXPERIMENTAL', 'label': 'Prototype nasal dilator', 'description': 'Prototype nasal dilator', 'interventionNames': ['Device: Prototype Nasal Dilator']}], 'interventions': [{'name': 'Marketed Nasal Strip', 'type': 'DEVICE', 'description': 'Breathe Right Nasal Strips - Clear small/medium strip', 'armGroupLabels': ['Marketed nasal strip']}, {'name': 'Prototype Nasal Dilator', 'type': 'DEVICE', 'description': 'Prototype Nasal Dilator AB2R11', 'armGroupLabels': ['Prototype nasal dilator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07044', 'city': 'Verona', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Essex Testing Clinic, Inc', 'geoPoint': {'lat': 40.82982, 'lon': -74.24015}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}