Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy

NCT01697722 | Completed DMC

• 1 other identifier: BA21
• Study Type: observational
• Target: 815,377
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of asthma management in patients with evidence of persistent asthma following an increase in asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS) using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone propionate / salmeterol \[FP/SAL\] or budesonide / formoterol \[BUD/FOR\]) or separate pMDIs and BAIs.

Conditions

Asthma

Keywords

Primary care; Asthma management; Inhaled corticosteroids; Extra-fine hydrofluoroalkane; Long-acting beta-agonist; Fixed-dose combination therapy

Outcome Measures

Primary Outcomes (1)

• Proxy asthma control

  * 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 (4)

• Success of therapeutic regimen

  One-year outcome period

• Success of therapeutic regimen (sensitivity - independent of cost saving)

  One-year outcome period

• average SABA daily dose during outcome year

  One-year outcome period

• Hospitalisations

  One-year outcome period

Study Arms (3)

Step-up as FDC ICS/LABA

ICS asthma patients who increased therapy as FDC ICS/LABA (no increase in daily ICS dose).

Step up as separate therapies

ICS asthma patients who increased therapy as ICS / LABA via separate pMDI and / or BAI inhalers (no increase in daily ICS dose).

Drug: ICS / LABA via separate pMDI and / or BAI inhalers

Qvar step-up

ICS asthma patients who increased therpy as extra-fine hydrofluoroalkane-beclometasone dipropionate

Drug: Extra-fine hydrofluoroalkane-beclometasone dipropionate

Interventions

Extra-fine hydrofluoroalkane-beclometasone dipropionate DRUG

Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI

Also known as: Qvar

Qvar step-up

ICS / LABA via separate pMDI and / or BAI inhalers DRUG

A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose

Also known as: ICS+LABA separates

Step up as separate therapies

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care asthma patients who were receiving ICS therapy (any of BDP, extrafine BDP-HFA, BUD or FP as pMDI or BAI) who, at an index prescription date, underwent either: (i) an increase in ICS as extrafine HFA-BDP (pMDI or BAI); (ii) a change to combination therapy with a separate LABA pMDI or BAI (no change in drug, device or daily BDP-equivalent dose) (iii) a change to combination therapy via a fixed-combination inhaler (with no increase in daily BDP-equivalent dose).

You may qualify if:

• Aged: 4-60 years:
• Paediatric cohort (aged 4-11 years), and
• Adult cohort (aged 12-60 years)
• Aged 61-80 years and never smoked for an additional elderly cohort;
• Evidence of asthma: i.e. a diagnostic code of asthma or at least 2 asthma prescriptions, including one ICS prescription, at different points in time during the year prior to IPD (the baseline year)
• Be on current asthma therapy: i.e. at least 1 asthma prescription in the year prior to IPD, and at least 1 other asthma prescription during the same period
• 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).

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 (other than asthma)
• any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year

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, United Kingdom

Location

Related Publications (8)

• 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

• 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.

  PMID: 16275363 BACKGROUND

• Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung, and Blood Institute, National Institutes of Health, 2007. (Accessed March 2008, at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf

  BACKGROUND

• Aubier M, Wettenger R, Gans SJ. Efficacy of HFA-beclomethasone dipropionate extra-fine aerosol (800 microg day(-1)) versus HFA-fluticasone propionate (1000 microg day(-1)) in patients with asthma. Respir Med. 2001 Mar;95(3):212-20. doi: 10.1053/rmed.2000.1025.

  PMID: 11266239 BACKGROUND

• Fairfax A, Hall I, Spelman R. A randomized, double-blind comparison of beclomethasone dipropionate extrafine aerosol and fluticasone propionate. Ann Allergy Asthma Immunol. 2001 May;86(5):575-82. doi: 10.1016/S1081-1206(10)62907-9.

  PMID: 11379810 BACKGROUND

• Lasserson TJ, Cates CK, Jones AB, Steele EH, White J. Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005309. doi: 10.1002/14651858.CD005309.pub3.

  PMID: 16625634 BACKGROUND

• Gross G, Thompson PJ, Chervinsky P, Vanden Burgt J. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma. Chest. 1999 Feb;115(2):343-51. doi: 10.1378/chest.115.2.343.

  PMID: 10027430 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

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

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor David Price

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: January 1, 1991
• Primary Completion: June 1, 2007
• Study Completion: February 1, 2010
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

GB (1)