Status:
COMPLETED
Qvar Versus Clenil, a General Practice Research Database Study
Lead Sponsor:
Research in Real-Life Ltd
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
4-80 years
Brief 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 fo...
Detailed Description
Current asthma guidelines in the UK are underpinned by evidence derived from randomised controlled trials (RCTs). Although RCT data are considered the gold standard, patients recruited to asthma RCTs ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 1991
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
56985 Patients enrolled
Trial Details
Trial ID
NCT01400217
Start Date
January 1 1991
End Date
October 1 2010
Last Update
October 30 2012
Active Locations (1)
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1
Research in Real Life Ltd
Cawston, Norfolk, United Kingdom, NR10 4FE