Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-01 @ 12:48 AM
Study NCT ID:
NCT01729351
Status:
COMPLETED
Last Update Posted:
2012-11-20
First Post:
2012-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Qvar Therapy in Smoking Asthmatics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012907', 'term': 'Smoking'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-14', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-14', 'lastUpdatePostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Control proxy incorporating SABA use', 'timeFrame': '1 year', 'description': 'Where control is defined as absence of:\n\n(i)Respiratory-related:\n\nHospital attendance or admission A\\&E attendance, OR Out of hours attendance, OR Out-patient department attendance\n\n(ii)GP consultations for lower respiratory tract infection\n\n(iii)Prescriptions for acute courses of oral steroids\n\n(iv)Average prescribed daily dose of albuterol or terbutaline of ≤200mg'}, {'measure': 'Asthma Exacerbations (ATS Definition)', 'timeFrame': '1 year', 'description': 'Defined as an absence of the the following:\n\n1. Asthma related hospital attendance or admission, OR A\\&E attendance, OR\n2. Use of acute oral steroids.'}], 'secondaryOutcomes': [{'measure': 'Exacerbation definition based on clinical experience', 'timeFrame': '1 year', 'description': 'Defined as:\n\n(i)Respiratory-related:\n\nHospital attendance / admissions OR A\\&E attendance OR Out of hours consultation OR GP consultation OR (ii) Use of acute oral steroids'}, {'measure': 'Asthma control proxy excluding SABA usage', 'timeFrame': '1 year', 'description': 'Control defined as absence of:\n\n(i) Respiratory-related:\n\nHospital attendance or admission A\\&E attendance, OR Out of hours attendance, OR Out-patient department attendance\n\n(ii)GP consultations for lower respiratory tract infection\n\n(iii)Prescriptions for acute courses of oral steroids'}, {'measure': 'Treatment Success', 'timeFrame': '1 year', 'description': 'Success defined as:\n\nNo respiratory-related:\n\nHospital attendance or admission A\\&E attendance, OR Out of hours consultation, OR Out-patient department attendance\n\nNo GP consultations for lower respiratory tract infection\n\nNo prescriptions for acute courses of oral steroids\n\nNo additional or change in therapy:\n\nIncreased dose of ICS (≥50% increase), and/or Change in ICS and/or Change in delivery device, and/or Use of additional therapy as defined by: LABA, theophylline, leukotriene receptor antagonists (LTRAs).'}, {'measure': 'Definite asthma-related hospitalisations', 'timeFrame': '1 year', 'description': 'Hospitalisations coded with an asthma read code'}, {'measure': 'ICS Compliance', 'timeFrame': '1 year', 'description': 'Based on prescription refills'}, {'measure': 'Incidence of oral thrust', 'timeFrame': '1 year', 'description': 'Identified as:\n\n1. Topical oral anti-fungal prescriptions, and / or\n2. Coded for oral candidiasis'}, {'measure': 'SABA Dose', 'timeFrame': '1 year', 'description': 'Average daily dose of short-acting beta-agonist over the outcome year'}, {'measure': 'Definite and probable asthma-related hospitalisations', 'timeFrame': '1 year', 'description': 'Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary Care', 'Particle size', 'beclomethasone dipropionate', 'Asthma Management', 'Maintenance Therapy', 'Metered-Dose Inhaler', 'Smoking'], 'conditions': ['Asthma', 'Smoking']}, 'referencesModule': {'references': [{'pmid': '20692026', 'type': 'BACKGROUND', 'citation': 'Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.'}, {'pmid': '21752116', 'type': 'BACKGROUND', 'citation': 'Barnes N, Price D, Colice G, Chisholm A, Dorinsky P, Hillyer EV, Burden A, Lee AJ, Martin RJ, Roche N, von Ziegenweidt J, Israel E. Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study. Clin Exp Allergy. 2011 Nov;41(11):1521-32. doi: 10.1111/j.1365-2222.2011.03820.x. Epub 2011 Jul 14.'}, {'pmid': '10212105', 'type': 'BACKGROUND', 'citation': 'Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999 May;54(5):413-9. doi: 10.1136/thx.54.5.413.'}, {'pmid': '19067497', 'type': 'BACKGROUND', 'citation': 'Ivanova JI, Birnbaum HG, Hsieh M, Yu AP, Seal B, van der Molen T, Emani S, Rosiello RA, Colice GL. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care. 2008 Dec;14(12):801-9.'}], 'seeAlsoLinks': [{'url': 'http://www.cprd.com', 'label': 'Clinical Practice Research Database'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care asthma population of current smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are all current smokers ages between 16-70 years with evidence of asthma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 16-70 years\n* Current smokers - explicitly coded in patient records or captured in patient questionnaires\n* Evidence of asthma diagnosis and current therapy: ≥2 prescriptions for asthma at different points in time during the baseline year ± a diagnostic code for asthma\n* On-going asthma therapy: ≥2 prescription for ICS during the outcome period (i.e. ≥1 prescription in addition to IPD prescription)\n* ≥2 years continuous data (i.e. ≥1 year of baseline plus ≥1 year of outcome data)\n\nExclusion Criteria:\n\nPatients will be excluded from the analysis if they have:\n\n* Any chronic respiratory disease other than asthma\n* Are prescribed:\n* Maintenance oral steroid therapy during the baseline year\n* Combination ICS/long-acting beta agonist (LABA) therapy during baseline year or at IPD\n* Multiple ICS prescriptions at IPD or immediately before .'}, 'identificationModule': {'nctId': 'NCT01729351', 'briefTitle': 'Qvar Therapy in Smoking Asthmatics', 'organization': {'class': 'NETWORK', 'fullName': 'Research in Real-Life Ltd'}, 'officialTitle': 'Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone and Chlorofluorocarbon Beclometasone in Smoking Asthma - a Retrospective, Real-life Observational Study in a UK Primary Care Asthma Population', 'orgStudyIdInfo': {'id': 'R01911'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IPDI EF HFA-BDP', 'description': 'Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date'}, {'label': 'IPDI FP', 'description': 'Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date'}, {'label': 'IPDI NEF HFA-BDP', 'description': 'Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date'}, {'label': 'IPDA EF HFA-BDP', 'description': 'Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date'}, {'label': 'IPDA FP', 'description': 'Patients increasing inhaled corticosteroid therapy as FP MDI at the index date'}, {'label': 'IPDA NEF HFA-BDP', 'description': 'Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Professor Price', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aberdeen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research in Real-Life Ltd', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor David Price', 'investigatorFullName': 'David Price', 'investigatorAffiliation': 'Research in Real-Life Ltd'}}}}