Qvar Versus Clenil, a General Practice Research Database Study
NCT ID: NCT01400217
Last Updated: 2012-10-30
Study Results
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Basic Information
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COMPLETED
56985 participants
OBSERVATIONAL
1991-01-31
2010-10-31
Brief Summary
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Detailed Description
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In response to the Montreal Protocol's ruling to phase out ozone-depleting chlorofluorocarbon (CFC) propellants in asthma inhalers, several hydrofluoroalkane-134a-propellant (HFA-) formulations of BDP have been developed. Two branded generic formulations currently available in the UK are Qvar® (Teva Pharmaceutical Industries Ltd) - an extra-fine-particle (\~1.1 microns) HFA-BDP (solution) formulation and Clenil® (Chiesi Limited) - a larger particle (\~2.9 microns) HFA-BDP (suspension) formulation.
The extra-fine particle formulation HFA-BDP formulation (Qvar®) has been shown to improve total and small airway deposition relative to CFC-BDP. As a result of the more even distribution through both the large and small airways of the lungs and data from short-term randomised clinical trials (RCTs), Qvar® dosing is recommended at approximately one half the dose of traditional CFC-BDP (average particle size \~3.5 microns). However, the larger-particle Clenil® is recommended for prescribing at the same dose as traditional CFC-BDP.
Further studies are required to understand whether the differences in particle size and airway distribution have an impact on asthma outcomes over the long-term.
This observational study will investigate the real-world effectiveness of extra-fine HFA-BDP (Qvar®) as compared with larger-particle HFA-BDP (Clenil®) in patients with asthma who: were new to ICS therapy; received an increase in their ICS dose, or switched / changed baseline ICS therapy to HFA-BDP with no change in BDP-equivalent ICS dose. We hypothesise that differences in effectiveness might become apparent over the longer term through a retrospective database analysis of one-year outcomes for the diverse patient population seen in primary care.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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IPDI EF HFA-BDP
Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date
extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
IPDI SP HFA-BDP
Patients initiating inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
IPDA SP HFA-BDP
Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
IPDA EF HFA-BDP
Patients increased inhaled corticosteroid therapy as extra fine particle HFA-BDP MDI at the index date
extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
IPDS SP HFA-BDP
Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
IPDS EF HFA-BDP
Patients increased inhaled corticosteroid therapy as extrafine particle HFA-BDP MDI at the index date
extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Interventions
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extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Paediatric cohort (aged 4-11 years), and
* Adult cohort (aged 12-80 years )
* Evidence of asthma and current asthma therapy:
* All cohorts (IPDI, IPDS, IPDA):
* a diagnostic code for asthma, and / or \*≥2 prescriptions for asthma at different points in time during the prior year and/or IPDI only: ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS prescription in addition to that received at IPD
IPDA and IPDS only:
* 1 ICS prescription in the baseline year, and
* 1 other asthma prescription during the baseline year.
\*Evidence of "current therapy":
* 2 prescription for ICS during the outcome year (i.e. ≥1 prescription in addition to the prescription at index date
* Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the IPD).
Exclusion Criteria
* Had any chronic respiratory disease, except asthma, at any time; and/or
* Patients on maintenance oral steroids during baseline year
* Received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or
* Received ICS therapy during baseline year via DPI (IPDA and IPDS cohorts only).
* If they received multiple ICS prescriptions on the same day at IPD or immediately before
4 Years
80 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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David Price
Professor David Price
Principal Investigators
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David Price, MD
Role: PRINCIPAL_INVESTIGATOR
Company Director
Locations
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Research in Real Life Ltd
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.
Vanden Burgt JA, Busse WW, Martin RJ, Szefler SJ, Donnell D. Efficacy and safety overview of a new inhaled corticosteroid, QVAR (hydrofluoroalkane-beclomethasone extrafine inhalation aerosol), in asthma. J Allergy Clin Immunol. 2000 Dec;106(6):1209-26. doi: 10.1067/mai.2000.111582.
Leach CL, Davidson PJ, Hasselquist BE, Boudreau RJ. Influence of particle size and patient dosing technique on lung deposition of HFA-beclomethasone from a metered dose inhaler. J Aerosol Med. 2005 Winter;18(4):379-85. doi: 10.1089/jam.2005.18.379.
Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998 Dec;12(6):1346-53. doi: 10.1183/09031936.98.12061346.
Busse WW, Brazinsky S, Jacobson K, Stricker W, Schmitt K, Vanden Burgt J, Donnell D, Hannon S, Colice GL. Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant. J Allergy Clin Immunol. 1999 Dec;104(6):1215-22. doi: 10.1016/s0091-6749(99)70016-3.
Davies RJ, Stampone P, O'Connor BJ. Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol provides equivalent asthma control to chlorofluorocarbon beclomethasone dipropionate at approximately half the total daily dose. Respir Med. 1998 Jun;92 Suppl A:23-31. doi: 10.1016/s0954-6111(98)90214-1.
Gross G, Thompson PJ, Chervinsky P, Vanden Burgt J. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma. Chest. 1999 Feb;115(2):343-51. doi: 10.1378/chest.115.2.343.
IBM SPSS Statistics. 2010. Statistics family. Available online at: www.spss.com/uk/software/statistics/
AS Institute Inc. 2010. Statistical Analysis with SAS/STAT Software. Available online at: www.SAS.com/offices/europe/uk/technologies/analytics/statistics/stat/ondex.html
Price D, Thomas M, Haughney J, Lewis RA, Burden A, von Ziegenweidt J, Chisholm A, Hillyer EV, Corrigan CJ. Real-life comparison of beclometasone dipropionate as an extrafine- or larger-particle formulation for asthma. Respir Med. 2013 Jul;107(7):987-1000. doi: 10.1016/j.rmed.2013.03.009. Epub 2013 May 3.
Other Identifiers
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007/11
Identifier Type: -
Identifier Source: org_study_id