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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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. .

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research in Real-Life Ltd
• Collaborators: i3 Research; Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Beclomethasone; Fluticasone; Xhance

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• had been diagnosed with any chronic respiratory disease at any time other than asthma

• received maintenance oral steroid therapy during baseline.

Updated inclusion criteria - used in the latest analysis:

• 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.

Updated exclusion criteria - used in the latest analysis:

• 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