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

NCT ID: NCT01242098

Last Updated: 2012-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is 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

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fostair switch cohort

Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair

Fixed-dose combination beclometasone dipropionate / formoterol

Intervention Type DRUG

Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy

Seretide continuation cohort

Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide

Fixed dose combination salmeterol / fluticasone

Intervention Type DRUG

Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy

Interventions

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Fixed dose combination salmeterol / fluticasone

Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy

Intervention Type DRUG

Fixed-dose combination beclometasone dipropionate / formoterol

Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy

Intervention Type DRUG

Other Intervention Names

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FP/SAL; Seretide® 125 BDP/FOR; Fostair® 100/6

Eligibility Criteria

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Inclusion Criteria

* Aged:

* 18-60 years:
* 61-80 years who are never-smokers
* Evidence of asthma:

* a diagnostic code for asthma, or
* ≥2 prescriptions for asthma at different points in time during the prior year
* Baseline FP/SAL therapy:

* ≥2 prescription for ICS/LABA therapy as FP/SAL (Seretide® 125).

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

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role collaborator

Research in Real-Life Ltd

NETWORK

Sponsor Role lead

Responsible Party

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Alison Chisholm

David Price

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Optimum Patient Care

Cawston, Norfolk, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.optimumpatientcare.org

Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)

Other Identifiers

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004/11

Identifier Type: -

Identifier Source: org_study_id

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