Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management

Asthma Clinical Trial

— QvarAsthma  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141439
• Other study ID #: BA4
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: March 13, 2013
• Start date: January 2001
• Est. completion date: July 2010

Study information

• Verified date: March 2013
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815377
• Est. completion date: July 2010
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Extra-fine hydrofluoroalkane-beclomethasone dipropionate
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
• Extra-fine hydrofluoroalkane-beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
• Fluticasone propionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
• Beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
• fluticasone propionate
Initiation of FP (any dose) via MDI in steroid naive patient
• Chlorofluorocarbon beclomethasone dipropionate
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient

Locations

Country	Name	City	State
United Kingdom	General Practice Research Database	London

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Teva Pharmaceutical Industries

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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. — View Citation

Herland K, Akselsen JP, Skjønsberg 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. — View 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. — View 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. Erratum in: Pharmacoeconomics 2002;20(12):853. — View Citation

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. — View 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. Review. — View Citation

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. Epub 2006 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proxy asthma control	Primary composite measure asthma control defined as: No recorded hospital attendance for asthma including admission, Accident & Emergency (A&E) attendance, out of hours attendance or Out-Patient Department (OPD) attendance, AND; No prescriptions for oral steroid, AND; No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.	One-year outcome period	No
Secondary	Revised asthma control	A revised definition of proxy asthma control for sensitivity analysis was defined as: No recorded hospital attendance for asthma including admission, A&E attendance, out of hours attendance or OPD attendance, AND; No prescriptions for oral steroid, AND; No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics; Average daily prescribed dose of salbutamol of no more than 200mcg and terbutaline 500mcg.	One-year outcome period	No
Secondary	Disaggregated components of the primary control outcome	Hospital admissions for asthma; Consultations and hospital attendances for LRTI requiring antibiotics; Prescriptions for oral steroids; SABA use	One-year outcome period	No
Secondary	Time to the first asthma exacerbation	Where an exacerbation is defined as: An occurrence of unscheduled hospital admission/A&E attendances for asthma AND/OR; Use of oral steroids.	One-year outcome period	No
Secondary	Success of the therapeutic regimen	Defined as: Exacerbation AND/OR; Increase in dose of ICS AND/OR; Change in ICS drug type AND/OR; Change in delivery device AND/OR; Use of additional therapy as defined by: LABAs, oral steroids, theophylline, leukotriene receptor antagonists (LTRAs)	One-year outcome period	No
Secondary	Use of anti-fungals	defined as incidences of definite oral candidiasis	One-year	No
Secondary	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	No

External Links

•   Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)