Overview

Device Mixing in Asthma, a General Practice Research Database Study

Status:
Completed
Trial end date:
2010-03-01
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 Easi-breathe® (EB) - beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever medication (short-acting beta2-agonist [SABA] therapy) via either a BAI (i.e. Easi-breathe® [EB] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI salbutamol).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Research in Real-Life Ltd
Collaborators:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Pharmaceutical Industries
Treatments:
Albuterol
Beclomethasone
Criteria
Inclusion Criteria:

- Aged: 4-80 years:

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

- Adult cohort (aged 12-80 years )

- Evidence of asthma:

- a diagnostic code for asthma, and / or

- ≥2 prescriptions for asthma at different points in time during the prior year
and/ or

- ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS
prescription (in addition to that received at IPD) - IPDI cohort only

- Be on current asthma therapy (for the IPDA cohort only):

- ≥1 ICS prescription in the prior year, and

- ≥1 other asthma prescription during the baseline year.

- 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

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

- received a long-acting beta2-agonsist (LABA) in addition to a separate ICS inhaler in
the baseline year

- received ICS therapy during baseline year via DPI (in IPDA cohort only).