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Completed

NCT Number: NCT01908075

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

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

FP/SAL

Drug

Other names: Seretide®

BDP/FOR

Drug

Other names: Fostair® 100/6

Primary outcomes

  1. Exacerbations : rate ratio

    Time frame: 1 year

    Where an exacerbation is defined as:

    (i) Asthma-related

    • Hospital attendance / admissions OR
    • Accident & Emergency (A&E) attendance OR (ii) Use of acute oral steroids.

    Where:

    • ≥1 oral steroid prescription occurs within 2 weeks of another, or
    • ≥1 hospitalisation occurs within 2 weeks of another, or
    • ≥1 hospitalisation occurs within 2 weeks of an oral steroid prescription

Secondary outcomes

  1. Exacerbation control

    Time frame: 1 year

    Proxy Asthma Control. The absence of exacerbation and the absence of antibiotic prescribing for lower respiratory tract infections (often a pragmatic prescribing decision taken by GPs in real world practice).

    Controlled:

    (i) No Asthma-related:

    • Hospital attendance or admission
    • A&E attendance, OR
    • Out of hours attendance, OR
    • Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids

    Uncontrolled:

    (i) All others.

    a. Proxy Asthma Control + SABA As above, but with an additional criterion that limits "controlled" patients to those who use ≤200mcg salbutamol daily.

  2. Proxy asthma control + SABA

    Time frame: 1 year

    As above, but with an additional criterion that limits "controlled" patients to those who use ≤200mcg salbutamol daily

  3. Treatment success

    Time frame: 1 year

    No exacerbation and no change in therapy during the outcome year, where changes are:

    •≥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).

  4. Asthma Control (including SABA)

    Time frame: 1 year

    Defined as proxy asthma control (above) plus:

    Average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline

  5. Hospitalisations

    Time frame: 1 year

    Asthma-related hospitalizations

    • 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

    Respiratory hospitalisations

    • Definite: Hospitalisations coded with a lower respiratory code relevant for Paeds (for example J450)
    • 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

  6. Medication possession ratio

    Time frame: 1 year

    For ICS, defined as the number of days supply of ICS / 365 x 100%

    Controller/reliever ratio: number of controller units/ number of controller units + number of reliever units. Controllers are defined as ICS (including fixed combination ICS/LABA) and LTRA, while relievers are SABA. For ICS a unit is taken to be one inhaler; for LTRA a unit is one prescription.

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

REACH Fostair vs Seretide - Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management

Acronym: REACH

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2013
Registry last updated
Jul 25, 2013

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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