Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management
NCT ID: NCT01141439
Last Updated: 2013-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
815377 participants
OBSERVATIONAL
2001-01-31
2010-07-31
Brief Summary
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Detailed Description
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A number of trends are emerged in asthma prescribing that warrant further investigation to ascertain their benefit to both the patient and the NHS. In particular, significant pressure exists to use the cheapest inhaler devices and formulations. An analysis of a pragmatic trial of Qvar versus standard CFC-BDP undertaken by Research in Real Life suggested that Qvar may be offer greater effectiveness in.5,6 In light of these data, the following report details the findings of a study designed to examine the effectiveness of Qvar in real-life clinical practice using the General Practice Research Database (GPRD).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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IPDI HFA-BDP MDI
Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI
Extra-fine hydrofluoroalkane-beclomethasone dipropionate
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
IPDI FP MDI
Patients who commenced inhaled corticosteroid therapy as FP via MDI
fluticasone propionate
Initiation of FP (any dose) via MDI in steroid naive patient
IPDA FP MDI
Patients who had a step up in inhaled corticosteroid therapy as FP via MDI
Fluticasone propionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
IPDA HFA-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI
Extra-fine hydrofluoroalkane-beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
IPDI CFC-BDP MDI
Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI
Chlorofluorocarbon beclomethasone dipropionate
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
IPDA CFC-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI
Beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
Interventions
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Extra-fine hydrofluoroalkane-beclomethasone dipropionate
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
Extra-fine hydrofluoroalkane-beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
Fluticasone propionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
Beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
fluticasone propionate
Initiation of FP (any dose) via MDI in steroid naive patient
Chlorofluorocarbon beclomethasone dipropionate
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 5-60 years
* evidence of asthma: a diagnostic code of asthma or ≥2 prescriptions for asthma in baseline year at different points in time including one of ICS
* on current therapy at the IPD, defined as ≥1 ICS script and ≥1 other asthma prescriptions in the 12 months prior to first change in therapy
* had definite dosing instructions
* have at least 1 year of up-to-standard (UTS) baseline data before IPD
* have at least 1 year of UTS outcome data after IPD.
Exclusion Criteria
* had a diagnostic read code for chronic respiratory disease at any time
* For the therapy increase patient cohort, any patients receiving a combination inhaler in addition to their separate ICS inhaler in the year prior to IPD were also excluded.
5 Years
60 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Research in Real-Life Ltd
NETWORK
Responsible Party
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Research in Real Life Limited
Principal Investigators
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David Price, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Company Director
Alison Chisholm, MSc
Role: STUDY_DIRECTOR
Research Project Director
Locations
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General Practice Research Database
London, London, United Kingdom
Countries
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References
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Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.
Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17.
Thomas M, Cleland J, Price D. Database studies in asthma pharmacoeconomics: uses, limitations and quality markers. Expert Opin Pharmacother. 2003 Mar;4(3):351-8. doi: 10.1517/14656566.4.3.351.
Tannen RL, Weiner MG, Xie D. Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings. BMJ. 2009 Jan 27;338:b81. doi: 10.1136/bmj.b81.
Juniper EF, Price DB, Stampone PA, Creemers JP, Mol SJ, Fireman P. Clinically important improvements in asthma-specific quality of life, but no difference in conventional clinical indexes in patients changed from conventional beclomethasone dipropionate to approximately half the dose of extrafine beclomethasone dipropionate. Chest. 2002 Jun;121(6):1824-32. doi: 10.1378/chest.121.6.1824.
Price D, Haughney J, Duerden M, Nicholls C, Moseley C. The cost effectiveness of chlorofluorocarbon-free beclomethasone dipropionate in the treatment of chronic asthma: a cost model based on a 1-year pragmatic, randomised clinical study. Pharmacoeconomics. 2002;20(10):653-64. doi: 10.2165/00019053-200220100-00002.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Cliniclue [homepage on the internet]. The Clinical Information Consultancy CLINICLUE® [updated 2008; cited 15 May 2009]. Available online at: http://www.cliniclue.com
SPSS [homepage on the internet]. Chicago: SPSS Inc [updated 2009; cited 15 May 2009]. Available online at: http://www.spss.com/UK/
Microsoft office online [homepage on the internet]. USA: Microsoft Corporation [updated 2009; cited 15 May 2009]. Available online at: http://office.microsoft.com/excel
STATA: Data Analysis and Statistical Software [homepage on the internet]. Texas: STATA [updated 2009; cited 15 May 2009]. Available online at: http://www.stata.com/
Related Links
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Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)
Other Identifiers
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BA4
Identifier Type: -
Identifier Source: org_study_id
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