Retrospective, Real-life Observational Evaluation of the Effectiveness and Cost-effectiveness of Extra-fine Hydrofluoroalkane (HFA) Beclometasone (BDP) Compared With Fluticasone Propionate (FP) in the Management of Asthma in a Representative Population in the United States (US) (USQvarAsthma)

NCT01287351 COMPLETED

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. .

Details

Lead sponsor	Research in Real-Life Ltd
Status	COMPLETED
Enrolment	82903
Start date	2004-01
Completion	2010-10

Conditions

• Asthma

Interventions

• extra-fine hydrofluoroalkane beclometasone dipropionate
• Fluticasone propionate

Primary outcomes

• Proxy Asthma Control — One-year outcome period
  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.
• Total number of asthma exacerbations and exacerbation rate ratio — One-year outcome period
  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
• Revised proxy asthma control — One-year outcome period
  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
• Risk Domain Asthma Control (in the subgroup of patients aged 12-60, the following additional analysis was done) — One year outcome period
  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.

Countries

United Kingdom