Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management (Fos/Ser_switch)

This study has been completed.
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Alison Chisholm, Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01242098
First received: November 11, 2010
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Asthma
Drug: Fixed dose combination salmeterol / fluticasone
Drug: Fixed-dose combination beclometasone dipropionate / formoterol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official 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

Resource links provided by NLM:


Further study details as provided by Research in Real-Life Ltd:

Primary Outcome Measures:
  • Exacerbation rate [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Where an exacerbation is defined as:

    (i) Asthma-related

    1. Hospital attendance / admissions OR
    2. Accident & Emergency (A&E) attendance OR

    (ii) Use of oral steroids.



Secondary Outcome Measures:
  • Exacerbation control (a composite proxy measure) [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Controlled:

    Absence of:

    (i) Asthma-related:

    1. Hospital attendance or admission
    2. A&E attendance, OR
    3. Out of hours consultations, OR
    4. Out-patient department attendance

    (ii) GP consultations for lower respiratory tract infection

    (iii) Prescriptions for acute courses of oral steroids


  • Treatment success 1 [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    (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).

  • Asthma hospitalisations [ Time Frame: One-year outcome period ] [ Designated as safety issue: Yes ]
    1. Definite: Hospitalisations coded with an asthma read code
    2. 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

  • Compliance with ICS/LABA therapy [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    Compliance calculation based on prescription refills and (where possible) compliance questionnaire data

  • Use of reliever medication [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    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.

  • Cost of therapeutic regimen. [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year

  • Asthma-related / respiratory hospitalisations [ Time Frame: one year outcome period ] [ Designated as safety issue: No ]
    1. Definite: Hospitalisations coded with a lower respiratory code
    2. 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

  • Oral Thrush [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Identified as:

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

    (ii) Coded for oral candidiasis



Enrollment: 137
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: Fixed-dose combination beclometasone dipropionate / formoterol
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Other Name: BDP/FOR; Fostair® 100/6
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
Drug: Fixed dose combination salmeterol / fluticasone
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Other Name: FP/SAL; Seretide® 125

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients receiving ICS/LABA therapy as FP/SAL (Seretide® 125) who, at an index prescription date (IPD) receive a routine asthma review* and either:

(i) Switched to BDP/FOR (Fostair®)at same or lower BDP-equivalent ICS dose;

OR,

(ii) Continues on FP/SAL (Seretide® 125) for the duration of the outcome period at the same or lower BDP-equivalent ICS dose prescribed at baseline.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242098

Locations
United Kingdom
Optimum Patient Care
Cawston, Norfolk, United Kingdom, NR10 4FE
Sponsors and Collaborators
Research in Real-Life Ltd
Chiesi Farmaceutici S.p.A.
  More Information

Additional Information:
No publications provided

Responsible Party: Alison Chisholm, David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT01242098     History of Changes
Other Study ID Numbers: 004/11
Study First Received: November 11, 2010
Last Updated: June 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
Asthma
Combination therapy
Primary care management
Switch
ICS/LABA
Fostair
Seretide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Beclomethasone
Fluticasone, salmeterol drug combination
Formoterol
Salmeterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents

ClinicalTrials.gov processed this record on April 17, 2014