Device Mixing in Asthma, a General Practice Research Database Study
NCT ID: NCT01313585
Last Updated: 2011-03-14
Study Results
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Basic Information
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COMPLETED
815377 participants
OBSERVATIONAL
1991-01-31
2010-03-31
Brief Summary
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Detailed Description
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Inhalation therapy is the cornerstone of asthma treatment, used for the delivery of 'reliever' bronchodilator therapy (e.g. salbutamol) as well as anti-inflammatory corticosteroid 'maintenance' or 'controller' therapy. Currently available inhaler devices include MDIs, breath-actuated MDIs (BAIs), and dry powder inhalers (DPIs). Both BAIs and DPIs are actuated by the patient's inhalation manoeuvre, while MDIs are actuated by the patient's pressing of a button, which must thus be coordinated with inhalation. The clinical effectiveness of inhalation therapy derives from delivery of drug to the target sites in the lungs, and evidence is mounting that suboptimal use of inhaler devices is a common problem contributing to compromised asthma control for many patients. Indeed, decreased asthma control has been linked to the number of mistakes when using MDIs for delivering inhaled corticosteroids (ICS).
There is also evidence that the ability of patients to use the different inhaler device types is variable. Nonetheless, recent reviews of RCTs, while recognising the importance of inhaler technique, have concluded that inhaler devices do not differ significantly in efficacy and that the cheapest inhaler device should be used. However, as results are based on RCTs they should be applied with care in light of the aforementioned issues around external validity of RCTs and the ability to extrapolate their findings across a broad patient population. Moreover, patients enrolled in RCTs typically receive extensive training and must demonstrate and maintain proper inhaler technique, seldom accomplished in a real-world setting.
The aim of this study is to compare the absolute and relative effectiveness of ICS (maintenance) plus SABA (reliever) therapy delivered via same-type devices (namely BDP via EB plus salbutamol via EB \[BAI\]) and that delivered via different device types (i.e. BDP via EB \[BAI\] plus SABA via MDI) in a real-life, representative, UK primary care asthma population.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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IPDA salbutamol MDI
receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI
Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI
IPDA salbutamol EB
receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe
Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
IPDI salbutamol EB
initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe
Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
IPDI salbutamol MDI
initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI
Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device
Interventions
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Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device
Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI
Eligibility Criteria
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Inclusion Criteria
* Paediatric cohort (aged 4-11 years), and
* Adult cohort (aged 12-80 years )
* Evidence of asthma:
* a diagnostic code for asthma, and / or
* ≥2 prescriptions for asthma at different points in time during the prior year and/ or
* ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS prescription (in addition to that received at IPD) - IPDI cohort only
* Be on current asthma therapy (for the IPDA cohort only):
* ≥1 ICS prescription in the prior year, and
* ≥1 other asthma prescription during the baseline year.
* 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
* received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or
* received a long-acting beta2-agonsist (LABA) in addition to a separate ICS inhaler in the baseline year
* received ICS therapy during baseline year via DPI (in IPDA cohort only).
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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Research in Real Life
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.
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.
Crompton GK, Barnes PJ, Broeders M, Corrigan C, Corbetta L, Dekhuijzen R, Dubus JC, Magnan A, Massone F, Sanchis J, Viejo JL, Voshaar T; Aerosol Drug Management Improvement Team. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med. 2006 Sep;100(9):1479-94. doi: 10.1016/j.rmed.2006.01.008. Epub 2006 Feb 21.
Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Respir J. 2009 Dec;18(4):243-9. doi: 10.4104/pcrj.2009.00029.
Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002 Feb;19(2):246-51. doi: 10.1183/09031936.02.00218402.
Lenney J, Innes JA, Crompton GK. Inappropriate inhaler use: assessment of use and patient preference of seven inhalation devices. EDICI. Respir Med. 2000 May;94(5):496-500. doi: 10.1053/rmed.1999.0767.
Molimard M, Raherison C, Lignot S, Depont F, Abouelfath A, Moore N. Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003 Fall;16(3):249-54. doi: 10.1089/089426803769017613.
Brocklebank D, Ram F, Wright J, Barry P, Cates C, Davies L, Douglas G, Muers M, Smith D, White J. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. Health Technol Assess. 2001;5(26):1-149. doi: 10.3310/hta5260.
Brocklebank D, Wright J, Cates C. Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering corticosteroids in asthma. BMJ. 2001 Oct 20;323(7318):896-900. doi: 10.1136/bmj.323.7318.896.
Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.
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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003/10
Identifier Type: -
Identifier Source: org_study_id
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