Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management

NCT ID: NCT01908075

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 194723 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-03-31

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).

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

BDP/FOR

Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose

FP/SAL

Intervention Type: DRUG

BDP/FOR

Intervention Type: DRUG

FP/SAL

Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose

FP/SAL

Intervention Type: DRUG

Interventions

FP/SAL

Intervention Type: DRUG

BDP/FOR

Intervention Type: DRUG

Other Intervention Names

Seretide®; Fostair® 100/6

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: collaborator

Research in Real-Life Ltd

NETWORK

Sponsor Role: lead

Responsible Party

David Price, Prof., MD

Professor David Price

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Price

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Other Identifiers

R04312

Identifier Type: -

Identifier Source: org_study_id