Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01134705
Status:
COMPLETED
Last Update Posted:
2012-05-23
First Post:
2010-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ustevatrials@tevapharm.com', 'phone': '215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BDP HFA 320 µg/Day', 'description': 'During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.', 'otherNumAtRisk': 236, 'otherNumAffected': 14, 'seriousNumAtRisk': 236, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.', 'otherNumAtRisk': 238, 'otherNumAffected': 12, 'seriousNumAtRisk': 238, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDP HFA 320 µg/Day', 'description': 'During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.5', 'pValueComment': 'A priori threshold for statistical significance is p\\<0.05', 'statisticalMethod': 'Repeated measures Analysis of covariance', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)', 'description': 'Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \\& PM) using the following scale:\n\n0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).\n\nThe total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDP HFA 320 µg/Day', 'description': 'During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.4', 'pValueComment': 'A priori threshold for statistical significance is p\\<0.05', 'statisticalMethod': 'Repeated measures ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)', 'description': 'Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM \\& PM) using the following scale:\n\n0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).\n\nThe total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BDP HFA 320 µg/Day', 'description': 'During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.2', 'pValueComment': 'A priori threshold for statistical significance is p\\<0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment, baseline and center in the model.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BDP HFA 320 µg/Day', 'description': 'During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '238'}]}, {'type': 'Intent to Treat Population', 'achievements': [{'comment': 'Participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.', 'groupId': 'FG000', 'numSubjects': '232'}, {'comment': 'Participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.', 'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '216'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'A total of 675 patients were screened and 574 patients were enrolled in the study and participated in the Run-in Period. Of the 574 enrolled patients, 474 were randomized to study treatment.', 'preAssignmentDetails': 'During the 7 to 21 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their twice daily allergic rhinitis symptoms to determine eligibility for randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BDP HFA 320 µg/Day', 'description': 'During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Demographic data are provided for the Intent to Treat population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'A participant may select more than one race type.', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'dispFirstSubmitDate': '2011-08-25', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-23', 'studyFirstSubmitDate': '2010-05-27', 'dispFirstSubmitQcDate': '2011-08-25', 'resultsFirstSubmitDate': '2012-04-23', 'studyFirstSubmitQcDate': '2010-06-01', 'dispFirstPostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-23', 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period', 'timeFrame': 'Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)', 'description': 'Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \\& PM) using the following scale:\n\n0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).\n\nThe total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period', 'timeFrame': 'Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)', 'description': 'Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM \\& PM) using the following scale:\n\n0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).\n\nThe total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.'}, {'measure': 'Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)', 'timeFrame': 'Baseline and Week 6', 'description': 'The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK (2011). BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.'}, {'type': 'RESULT', 'citation': 'Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol (Supplement); 107(11):A118 - Poster presentation.'}, {'type': 'RESULT', 'citation': 'Carr W, Meltzer EO, Finn A, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. Effective nasal symptom relief and improvement in health-related quality of life in subjects with perennial allergic rhinitis following 6-week'}, {'pmid': '24169062', 'type': 'DERIVED', 'citation': 'Meltzer EO, Korenblat PE, Lanier BQ, Kelley L, Tantry SK. Beclomethasone dipropionate nasal aerosol with an integrated dose counter: functionality and performance. Allergy Asthma Proc. 2013 Nov-Dec;34(6):534-41. doi: 10.2500/aap.2013.34.3707.'}, {'pmid': '23026182', 'type': 'DERIVED', 'citation': 'Nayak AS, Atiee GJ, Dige E, Maloney J, Nolte H. Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):404-10. doi: 10.2500/aap.2012.33.3605.'}, {'pmid': '22737708', 'type': 'DERIVED', 'citation': 'Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK. Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis. Allergy Asthma Proc. 2012 May-Jun;33(3):249-57. doi: 10.2500/aap.2012.33.3571.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent\n* Documented history of perennial allergic rhinitis\n* A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.\n* Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)\n* Other criteria apply\n\nExclusion Criteria:\n\n* History of physical findings of nasal pathology (within 60 days prior to screening visit)\n* Participation in any investigational drug study 30 days preceding screening visit\n* History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period\n* Use of any prohibited concomitant medications'}, 'identificationModule': {'nctId': 'NCT01134705', 'briefTitle': 'Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)', 'orgStudyIdInfo': {'id': 'BDP-AR-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BDP HFA 320 µg/day', 'description': 'During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.', 'interventionNames': ['Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.', 'interventionNames': ['Drug: Placebo Nasal Aerosol']}], 'interventions': [{'name': 'Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol', 'type': 'DRUG', 'otherNames': ['QNASL(TM)'], 'description': 'Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol', 'armGroupLabels': ['BDP HFA 320 µg/day']}, {'name': 'Placebo Nasal Aerosol', 'type': 'DRUG', 'description': 'HFA Vehicle Aerosol', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Clinical Study Site', 'geoPoint': {'lat': 34.05223, 'lon': 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