Clinical trial NCT01908075: Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
Official title: REACH Fostair vs Seretide - Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Primary care
Asthma management
Real-world
Observational
Fostair
Seretide
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2013-07-25
Enrollment: 194723
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients are diagnosed with asthma or COPD and aged between 18-80 years with all 61-80 year olds being non-smokers only

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; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.

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; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched. To evaluate respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database (in patients switched for cost rather than clinical reasons).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Any chronic respiratory disease other than asthma
* Are receiving maintenance oral steroid therapy during baseline period

Primary outcomes:
measure: Exacerbations : rate ratio
timeFrame: 1 year
Secondary outcomes:
measure: Exacerbation control
timeFrame: 1 year
measure: Proxy asthma control + SABA
timeFrame: 1 year
measure: Treatment success
timeFrame: 1 year
measure: Asthma Control (including SABA)
timeFrame: 1 year
measure: Hospitalisations
timeFrame: 1 year
measure: Medication possession ratio
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Aberdeen
name: David Price
role: PRINCIPAL_INVESTIGATOR
References: