Real-world Effectiveness and Cost-effectiveness of Qvar Versus FP, a US Study
NCT ID: NCT01287351
Last Updated: 2013-08-05
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
82903 participants
OBSERVATIONAL
2004-01-31
2010-10-31
Brief Summary
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Detailed Description
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Asthma management guidelines recommend long-term, daily anti-inflammatory controller therapy to attenuate the chronic airway inflammation of persistent asthma. The choice of inhaled corticosteroid can be guided by practical considerations (e.g., cost factors) as RCTs have so far failed to identify consistent, significant differences in outcomes among the available inhaled corticosteroids, and data from observational studies are lacking.
FP and HFA-BDP are the two main ICS therapies prescribed in the US for the management of asthma. FP is approximately twice as potent and efficacious, on a microgram basis, as BDP. In clinical trials, however, the extra-fine hydrofluoroalkane (HFA) formulation of BDP has demonstrated potency similar to that of FP. This is felt to be because HFA-BDP shows higher and more even lung deposition than FP, with HFA-BDP, unlike FP, having distribution to both large and small airways.
Owing to similarity of effectiveness of extra-fine HFA-BDP and FP suggested by clinical trial data, and the even lung distribution afforded by the smaller HFA aerosol particles, we hypothesises that extra-fine HFA-BDP may be at least as effective as FP in real-world clinical practice. This hypothesis was supported by a retrospective database study of HFA-BDP versus FP using the UK's General Practice Research Database (GPRD). The study found significantly lower odds for achieving the composite proxy measure for asthma control with FP in both patients initiating ICS therapy (0.77, 95%CI 0.61-0.98) and stepping-up ICS therapy (0.82, 95%CI 0.44-1.52) relative to HFA-BDP. The analysis also revealed that FP was prescribed at significantly higher doses than extra-fine HFA-BDP yet had lower associated odds of achieving asthma control.
In addition to significant health benefits, delivering effective asthma control is critical to reducing the substantial economic burden of asthma, with research indicating annual costs are disproportionately attributable to patients with poorly controlled disease. Recent estimates place the annual figure at 56 billion dollars ($) in the US alone, consisting of direct costs and productivity losses.It is therefore of particular importance to consider outcomes achieved in relation to costs incurred when assessing overall benefit of asthma therapies, with a cost-effectiveness analysis of HFA BDP and FP planned as part of the current study.
The aim of this study is to compare the absolute and relative effectiveness and cost-effectiveness of asthma management in patients in the US on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI to further examine the findings of the UK study, and to identify similarities or differences in effectiveness and cost-effectiveness outcomes and prescribing practice between the two countries.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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IPDI: Qvar
ICS initiation as Qvar
extra-fine hydrofluoroalkane beclometasone dipropionate
IPDI FP
ICS initiation as fluticasone
Fluticasone propionate
IPDA Qvar
ICS step-up as Qvar
extra-fine hydrofluoroalkane beclometasone dipropionate
IPDA FP
ICS step-up as fluticasone
Fluticasone propionate
Interventions
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extra-fine hydrofluoroalkane beclometasone dipropionate
Fluticasone propionate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Paediatric cohort (aged 5-11 years), and
* Adult cohort (aged 12-60 years)
* Non-smokers aged 61-80 years
* Evidence of asthma:
* a diagnostic code for asthma, (ICD 9 codes: 493xx) or
* ≥2 prescriptions for asthma at different points at any time
* Be on current asthma therapy
* ≥1 other asthma prescription during the outcome period
* Have at least one year of baseline data (prior to the IPD) and at least one year of outcome data (following the IPD).
* Aged 12-60 years (paediatrics included in original study - removed to make comparable with USA data)
* Evidence of asthma: a diagnostic code of asthma or ≥2 scripts for asthma in baseline year at different points in time
* Have 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. Index dates from 1998 onwards were accepted in the study.
Exclusion Criteria
* received maintenance oral steroid therapy during baseline.
* Had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any time
* Had a diagnostic read code for chronic respiratory disease at any time
* Were on maintenance oral steroid therapy at baseline
5 Years
80 Years
ALL
No
Sponsors
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i3 Research
INDUSTRY
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Research in Real-Life Ltd
NETWORK
Responsible Party
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David Price, Prof., MD
Professor David Price
Locations
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Research in Real Life
Cawston, Norfolk, 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.
Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034.
Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung, and Blood Institute, National Institutes of Health, 2007. (Accessed March 2008, at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.)
British Guideline on the Management of Asthma, May 2008. 2008. (Accessed 26 June 2008, at http://www.sign.ac.uk/guidelines/fulltext/101/index.html.)
Global Strategy for Asthma Management and Prevention, updated 2008. 2008. (Accessed at http://www.ginasthma.org.)
Fanta CH. Asthma. N Engl J Med. 2009 Mar 5;360(10):1002-14. doi: 10.1056/NEJMra0804579. No abstract available.
Shepherd J, Rogers G, Anderson R, Main C, Thompson-Coon J, Hartwell D, Liu Z, Loveman E, Green C, Pitt M, Stein K, Harris P, Frampton GK, Smith M, Takeda A, Price A, Welch K, Somerville M. Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and over. Health Technol Assess. 2008 May;12(19):iii-iv, 1-360. doi: 10.3310/hta12190.
Aubier M, Wettenger R, Gans SJ. Efficacy of HFA-beclomethasone dipropionate extra-fine aerosol (800 microg day(-1)) versus HFA-fluticasone propionate (1000 microg day(-1)) in patients with asthma. Respir Med. 2001 Mar;95(3):212-20. doi: 10.1053/rmed.2000.1025.
Fairfax A, Hall I, Spelman R. A randomized, double-blind comparison of beclomethasone dipropionate extrafine aerosol and fluticasone propionate. Ann Allergy Asthma Immunol. 2001 May;86(5):575-82. doi: 10.1016/S1081-1206(10)62907-9.
Lasserson TJ, Cates CK, Jones AB, Steele EH, White J. Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005309. doi: 10.1002/14651858.CD005309.pub3.
Teva Pharmaceutical Industries, 2010. Data on file.
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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002/10
Identifier Type: -
Identifier Source: org_study_id