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Completed

NCT Number: NCT01242098

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Optimum Patient Care

Cawston, Norfolk, NR10 4FE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fixed dose combination salmeterol / fluticasone

Drug

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

Other names: FP/SAL; Seretide® 125

Fixed-dose combination beclometasone dipropionate / formoterol

Drug

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

Other names: BDP/FOR; Fostair® 100/6

Primary outcomes

  1. Exacerbation rate

    Time frame: One-year outcome period

    Where an exacerbation is defined as:

    (i) Asthma-related

    • Hospital attendance / admissions OR
    • Accident & Emergency (A&E) attendance OR

    (ii) Use of oral steroids.

Secondary outcomes

  1. Exacerbation control (a composite proxy measure)

    Time frame: One-year outcome period

    Controlled:

    Absence of:

    (i) Asthma-related:

    • Hospital attendance or admission
    • A&E attendance, OR
    • Out of hours consultations, OR
    • Out-patient department attendance

    (ii) GP consultations for lower respiratory tract infection

    (iii) Prescriptions for acute courses of oral steroids

  2. Treatment success 1

    Time frame: One-year outcome period

    (i) Exacerbation control

    AND

    (ii) No change in therapeutic regimen:

    • ≥50% increase in ICS dose relative to IPD dose, and/or
    • Change in ICS/LABA drug within class, and/or
    • Change in delivery device, and/or
    • Use of additional (defined as not received during baseline year) therapy as defined by: theophylline, leukotriene receptor antagonists (LTRAs).

  3. Asthma hospitalisations

    Time frame: One-year outcome period

    • Definite: Hospitalisations coded with an asthma read code
    • Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code

  4. Compliance with ICS/LABA therapy

    Time frame: One-year outcome period

    Compliance calculation based on prescription refills and (where possible) compliance questionnaire data

  5. Use of reliever medication

    Time frame: One-year outcome period

    average daily dosage during outcome year. Outcome SABA usage will be categorised within ranges used to match baseline SABA use to optimise matching of the treatment arms.

  6. Cost of therapeutic regimen.

    Time frame: One-year outcome period

    Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year

  7. Asthma-related / respiratory hospitalisations

    Time frame: one year outcome period

    • Definite: Hospitalisations coded with a lower respiratory code
    • Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code

  8. Oral Thrush

    Time frame: One-year outcome period

    Identified as:

    (i) Topical oral anti-fungal prescriptions, and / or

    (ii) Coded for oral candidiasis

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK Primary Care Asthma Management

Acronym: Fos/Ser_switch

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2010
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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