Overview

Qvar Versus Clenil, a General Practice Research Database 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 of asthma management in patients on inhaled corticosteroid (ICS) maintenance therapy as either extra-fine-particle or larger-particle formulation beclomethasone dipropionate (BDP) via metered-dose inhalers (MDIs) using the propellant hydrofluoroalkane propellant (HFA-BDP), namely Qvar® MDI compared with Clenil® MDI.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Research in Real-Life Ltd
Collaborators:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Pharmaceutical Industries
Treatments:
Beclomethasone
Criteria
Inclusion Criteria:

- Aged: 4-80 years

- Paediatric cohort (aged 4-11 years), and

- Adult cohort (aged 12-80 years )

- Evidence of asthma and current asthma therapy:

- All cohorts (IPDI, IPDS, IPDA):

- a diagnostic code for asthma, and / or *≥2 prescriptions for asthma at different
points in time during the prior year and/or IPDI only: ≥2 prescriptions for
asthma therapies during the outcome year, including ≥1 ICS prescription in
addition to that received at IPD

IPDA and IPDS only:

- 1 ICS prescription in the baseline year, and

- 1 other asthma prescription during the baseline year.

*Evidence of "current therapy":

- 2 prescription for ICS during the outcome year (i.e. ≥1 prescription in addition to
the prescription at index date

- 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).

Exclusion Criteria:

- Had a COPD read code at any time; and/or

- Had any chronic respiratory disease, except asthma, at any time; and/or

- Patients on maintenance oral steroids during baseline year

- Received a combination inhaler in addition to a separate ICS inhaler in the baseline
year; and/or

- Received ICS therapy during baseline year via DPI (IPDA and IPDS cohorts only).

- If they received multiple ICS prescriptions on the same day at IPD or immediately
before