Clinical trial NCT01141439: Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management
Official title: A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Primary care
Asthma management
Inhaled corticosteroids
Beclomethasone dipropionate
Fluticasone propionate
Metred dose inhaler
Extra-fine hydrofluoroalkane
Chlorofluorocarbon
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2010-06-10
Enrollment: 815377
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

Included patients must:

* 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 obstructive pulmonary disease (COPD) at any time
* 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.

Primary outcomes:
measure: Proxy asthma control
timeFrame: One-year outcome period
Secondary outcomes:
measure: Revised asthma control
timeFrame: One-year outcome period
measure: Disaggregated components of the primary control outcome
timeFrame: One-year outcome period
measure: Time to the first asthma exacerbation
timeFrame: One-year outcome period
measure: Success of the therapeutic regimen
timeFrame: One-year outcome period
measure: Use of anti-fungals
timeFrame: One-year
measure: 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.
timeFrame: One-year outcome period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: General Practice Research Database
Study officials:
affiliation: Company Director
name: David Price, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Project Director
name: Alison Chisholm, MSc
role: STUDY_DIRECTOR
References:
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citation: 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.
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citation: 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.
citation: 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.
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