Status:
COMPLETED
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
Lead Sponsor:
Research in Real-Life Ltd
Collaborating Sponsors:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Brief Summary
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Sere...
Detailed Description
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Sere...
Eligibility Criteria
Inclusion
- Aged: 18-80 years 61-80 years to be non-smokers only
- Evidence of asthma: a diagnostic code for asthma or two scripts for asthma..
- Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL
- Evidence of Continuing Therapy: Include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). UK average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of "real-life" data.
- Evidence of Switching for economic reasons: FP/SAL patients from practices with ≥5 switches to Fostair in a 3 month period to minimise data taken from switching of anomalous patients; optimal practices for inclusion are those switching "wholesale" for economic reasons.
Exclusion
- Any chronic respiratory disease other than asthma
- Are receiving maintenance oral steroid therapy during baseline period
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
194723 Patients enrolled
Trial Details
Trial ID
NCT01908075
Start Date
January 1 2011
End Date
March 1 2013
Last Update
July 25 2013
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