Real-world Effectiveness and Cost-effectiveness of Qvar Versus FP, a US Study

NCT01287351 | Completed

• 1 other identifier: 002/10
• Study Type: observational
• Target: 82,903
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the absolute and relative effectiveness and cost-effectiveness of asthma management in patients in the USA on inhaled corticosteroid (ICS) maintenance therapy as HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI. .

Conditions

Asthma

Keywords

Real-world; observational; Fluticasone propionate; Metred dose inhaler; Extra-fine hydrofluoroalkane; Asthma management; Inhaled corticosteroids; Beclomethasone dipropionate; USA

Outcome Measures

Primary Outcomes (4)

• Proxy Asthma Control

  1. No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance or Out-Patient Department (OPD) attendance, AND 2. No prescriptions for acute courses of oral steroids, AND 3. No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics.

  One-year outcome period

• Total number of asthma exacerbations and exacerbation rate ratio

  Where exacerbations are defined as an occurrence of: 1. Unscheduled hospital admissions / Emergency Room attendance for asthma, OR 2. Use of acute courses of oral steroids

  One-year outcome period

• Revised proxy asthma control

  No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance, out-of-hours attendance, or Out-Patient Department (OPD) attendance, AND No prescriptions for acute courses of oral steroids, AND No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics. Average daily, prescribed dose of ≤180mcg salbutamol / albuterol or ≤500mcg terbutaline

  One-year outcome period

• Risk Domain Asthma Control (in the subgroup of patients aged 12-60, the following additional analysis was done)

  Where control is defined as the absence of the following during the one-year outcome period: 1. Asthma-related : * Hospital attendance or admission, OR * A\&E attendance, OR * Out of hours attendance, OR * Out-patient department attendance 2. GP consultations for lower respiratory tract infection 3. Prescriptions for acute courses of oral steroids.

  One year outcome period

Secondary Outcomes (6)

• Asthma control plus no additional or change in therapy

  One-year outcome period

• Asthma control plus no additional change in therapy (where change is not driven by possible cost saving)

  One-year outcome period

• Respiratory-related hospitalizations and referrals

  One-year outcome period

• Overall asthma control (Risk and Impairment) (in the subgroup of patients aged 12-60, the following additional analysis was done)

  One year outcome period

• Health Economic analysis

  One year outcome period

Study Arms (4)

IPDI: Qvar

ICS initiation as Qvar

Drug: extra-fine hydrofluoroalkane beclometasone dipropionate

IPDI FP

ICS initiation as fluticasone

Drug: Fluticasone propionate

IPDA Qvar

ICS step-up as Qvar

Drug: extra-fine hydrofluoroalkane beclometasone dipropionate

IPDA FP

ICS step-up as fluticasone

Drug: Fluticasone propionate

Interventions

extra-fine hydrofluoroalkane beclometasone dipropionate DRUG

Also known as: Qvar®

IPDA Qvar; IPDI: Qvar

Fluticasone propionate DRUG

IPDA FP; IPDI FP

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

Asthma patients who either: (i) Initiate ICS therapy as one of: * HFA-BDP pMDI * FP pMDI OR (ii) Step up ICS therapy as one of: * HFA-BDP pMDI * FP pMDI

You may qualify if:

• Aged: 5-80 years:
• Paediatric cohort (aged 5-11 years), and
• Adult cohort (aged 12-60 years)
• Non-smokers aged 61-80 years
• Evidence of asthma:
• a diagnostic code for asthma, (ICD 9 codes: 493xx) or
• ≥2 prescriptions for asthma at different points at any time
• Be on current asthma therapy
• ≥1 other asthma prescription during the outcome period
• Have at least one year of baseline data (prior to the IPD) and at least one year of outcome data (following the IPD).

You may not qualify if:

• had been diagnosed with any chronic respiratory disease at any time other than asthma
• received maintenance oral steroid therapy during baseline.
• Aged 12-60 years (paediatrics included in original study - removed to make comparable with USA data)
• Evidence of asthma: a diagnostic code of asthma or ≥2 scripts for asthma in baseline year at different points in time
• Have 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. Index dates from 1998 onwards were accepted in the study.
• 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
• Were on maintenance oral steroid therapy at baseline

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• i3 Research: collaborator
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Research in Real Life

Cawston, Norfolk, NR10 4FE, United Kingdom

Location

Related Publications (12)

• 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

• British Guideline on the Management of Asthma, May 2008. 2008. (Accessed 26 June 2008, at http://www.sign.ac.uk/guidelines/fulltext/101/index.html.)

  BACKGROUND

• Global Strategy for Asthma Management and Prevention, updated 2008. 2008. (Accessed at http://www.ginasthma.org.)

  BACKGROUND

• Fanta CH. Asthma. N Engl J Med. 2009 Mar 5;360(10):1002-14. doi: 10.1056/NEJMra0804579. No abstract available.

  PMID: 19264689 BACKGROUND

• Shepherd J, Rogers G, Anderson R, Main C, Thompson-Coon J, Hartwell D, Liu Z, Loveman E, Green C, Pitt M, Stein K, Harris P, Frampton GK, Smith M, Takeda A, Price A, Welch K, Somerville M. Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and over. Health Technol Assess. 2008 May;12(19):iii-iv, 1-360. doi: 10.3310/hta12190.

  PMID: 18485271 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

• Teva Pharmaceutical Industries, 2010. Data on file.

  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 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: January 28, 2011
• First Posted: February 1, 2011
• Study Start: January 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: October 1, 2010
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

GB (1)