Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00116818
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-06-30', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects'}], 'secondaryOutcomes': [{'measure': 'Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.'}]}, 'conditionsModule': {'keywords': ['perennial allergic rhinitis', 'intranasal corticosteroid', 'HPA axis function', 'GW685698X'], 'conditions': ['Rhinitis, Allergic, Perennial']}, 'referencesModule': {'availIpds': [{'id': 'FFR20002', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR20002', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR20002', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR20002', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR20002', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR20002', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR20002', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'type': 'RESULT', 'citation': 'Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on hypothalamic-pituitary-adrenal (HPA) axis function by once-daily fluticasone furoate* nasal spray (FFNS) 110 mcg in adolescents and adults with perennial allergic rhinitis (PAR).'}, {'type': 'RESULT', 'citation': 'Patel P, Ratner P, Clements D, Wu W, Philpot E. Twenty-four hour serum and urine cortisol data support hypothalamic-pituitary adrenocortical axis safety of once-daily fluticasone furoate*nasal spray 110mcg in adolescents and adults with perennial allerg'}, {'pmid': '18517083', 'type': 'DERIVED', 'citation': 'Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on adult and adolescent hypothalamic-pituitary-adrenal axis function with use of fluticasone furoate nasal spray. Ann Allergy Asthma Immunol. 2008 May;100(5):490-6. doi: 10.1016/S1081-1206(10)60476-0.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.', 'detailedDescription': 'A randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis and history of perennial allergic rhinitis.\n* Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.\n* Must comply with all study procedures and be literate.\n\nExclusion criteria:\n\n* Use of tobacco products.\n* Work a rotating shift.\n* Significant concurrent medical conditions.\n* Certain medications such as corticosteroids and allergy medications.'}, 'identificationModule': {'nctId': 'NCT00116818', 'briefTitle': 'A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-blind, Parallel Group, Placebo and Active (Prednisone) Controlled, 6-week Study of the Effect of Fluticasone Furoate Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Adolescents and Adults 12 to 65 Years of Age With Perennial Allergic Rhinitis (PAR)', 'orgStudyIdInfo': {'id': 'FFR20002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: GW685698X aqueous nasal spray']}], 'interventions': [{'name': 'GW685698X aqueous nasal spray', 'type': 'DRUG', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'L4W 1N2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}