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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
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The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and paediatrics (5-11yrs).
While current UK asthma guidelines are underpinned with evidence from RCTs, much of this evidence has been undertaken in patients who are not representative of the majority of the current UK asthma population. In fact it has been estimated that fewer than 10% of the patients seen in everyday clinical practice would be eligible for inclusion in such trials. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is therefore a need for more representative RCTs and real-life and observational studies to inform existing guidelines and help optimise asthma outcomes. A more holistic approach to respiratory research would see RCT evidence complimented by "real-life" data from pragmatic trials and observational studies.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPDI HFA-BDP MDI | Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI |
| |
| IPDI FP MDI | Patients who commenced inhaled corticosteroid therapy as FP via MDI |
| |
| IPDA FP MDI | Patients who had a step up in inhaled corticosteroid therapy as FP via MDI |
| |
| IPDA HFA-BDP MDI | Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI |
| |
| IPDI CFC-BDP MDI | Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI |
| |
| IPDA CFC-BDP MDI | Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-fine hydrofluoroalkane-beclomethasone dipropionate | Drug | Initiation of HFA-BDP (any dose) in steroid naive patients via MDI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proxy asthma control | Primary composite measure asthma control defined as:
| One-year outcome period |
| Measure | Description | Time Frame |
|---|---|---|
| Revised asthma control | A revised definition of proxy asthma control for sensitivity analysis was defined as:
|
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Inclusion Criteria:
Included patients must:
Exclusion Criteria:
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Primary care asthma patients receiving who either initiated ICS therapy as any of extrafine HFA-BDP, CFC-BDP of FP via MDI at an index prescription date (IPD), or were on existing ICs therapy (any) and had an increase in ICS dose at IPD as any of extrafine HFA-BDP, CFC-BDP of FP via MDI
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| Name | Affiliation | Role |
|---|---|---|
| David Price, Prof. MD | Company Director | Principal Investigator |
| Alison Chisholm, MSc | Research Project Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Practice Research Database | London | London | SW8 5NQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15672843 | Background | 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. | |
| 17113277 | Background | 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. |
| Label | URL |
|---|---|
| Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation) | View source |
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|
| Extra-fine hydrofluoroalkane-beclomethasone dipropionate | Drug | An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI |
|
|
| Fluticasone propionate | Drug | An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI |
|
| Beclomethasone dipropionate | Drug | An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI |
|
| fluticasone propionate | Drug | Initiation of FP (any dose) via MDI in steroid naive patient |
|
| Chlorofluorocarbon beclomethasone dipropionate | Drug | Initiation of CFC-BDP (any dose) via MDI in steroid naive patient |
|
| One-year outcome period |
| Disaggregated components of the primary control outcome |
| One-year outcome period |
| Time to the first asthma exacerbation | Where an exacerbation is defined as:
| One-year outcome period |
| Success of the therapeutic regimen | Defined as:
| One-year outcome period |
| Use of anti-fungals | defined as incidences of definite oral candidiasis | One-year |
| Daily dose of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP Daily dose* of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP. | BDP-equivalent dose were calculated by multiplying the Qvar and FP doses by a factor of 2. The dose at week 52 was compared with that at week 0 in order to identify the proportion of original (week 0) ICS dose. | One-year outcome period |
| 12614187 | Background | 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. |
| 19174434 | Background | 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. |
| 12065345 | Background | 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. |
| 12162754 | Background | 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. |
| 3558716 | Background | 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. |
| Background | Cliniclue [homepage on the internet]. The Clinical Information Consultancy CLINICLUE® [updated 2008; cited 15 May 2009]. Available online at: http://www.cliniclue.com |
| Background | SPSS [homepage on the internet]. Chicago: SPSS Inc [updated 2009; cited 15 May 2009]. Available online at: http://www.spss.com/UK/ |
| Background | Microsoft office online [homepage on the internet]. USA: Microsoft Corporation [updated 2009; cited 15 May 2009]. Available online at: http://office.microsoft.com/excel |
| Background | 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/ |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
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