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

NCT01141439 | Completed DMC

• 1 other identifier: BA4
• Study Type: observational
• Target: 815,377
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma

Keywords

Primary care; Asthma management; Inhaled corticosteroids; Beclomethasone dipropionate; Fluticasone propionate; Metred dose inhaler; Extra-fine hydrofluoroalkane; Chlorofluorocarbon

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Revised asthma control

  One-year outcome period

• Disaggregated components of the primary control outcome

  One-year outcome period

• Time to the first asthma exacerbation

  One-year outcome period

• Success of the therapeutic regimen

  One-year outcome period

• Use of anti-fungals

  One-year

Study Arms (6)

IPDI HFA-BDP MDI

Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI

Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate

IPDI FP MDI

Patients who commenced inhaled corticosteroid therapy as FP via MDI

Drug: fluticasone propionate

IPDA FP MDI

Patients who had a step up in inhaled corticosteroid therapy as FP via MDI

Drug: Fluticasone propionate

IPDA HFA-BDP MDI

Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI

Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate

IPDI CFC-BDP MDI

Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI

Drug: Chlorofluorocarbon beclomethasone dipropionate

IPDA CFC-BDP MDI

Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI

Drug: Beclomethasone dipropionate

Interventions

Extra-fine hydrofluoroalkane-beclomethasone dipropionate DRUG

Initiation of HFA-BDP (any dose) in steroid naive patients via MDI

Also known as: Qvar®

IPDI HFA-BDP MDI

fluticasone propionate DRUG

An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI

IPDA FP MDI

Beclomethasone dipropionate DRUG

An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI

IPDA CFC-BDP MDI

Chlorofluorocarbon beclomethasone dipropionate DRUG

Initiation of CFC-BDP (any dose) via MDI in steroid naive patient

IPDI CFC-BDP MDI

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

General Practice Research Database

London, London, SW8 5NQ, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 15672843 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.

  PMID: 17113277 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.

  PMID: 12614187 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.

  PMID: 19174434 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.

  PMID: 12065345 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.

  PMID: 12162754 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.

  PMID: 3558716 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/

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Androstadienes; Androstenes; Androstanes

Study Officials

• David Price, Prof. MD

  Company Director

  PRINCIPAL INVESTIGATOR

• Alison Chisholm, MSc

  Research Project Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: January 1, 2001
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2010
• Last Updated: March 14, 2013

Record last verified: 2013-03

Locations

GB (1)