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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Fixed-dose combination beclometasone dipropionate / formoterol; Drug: Fixed dose combination salmeterol / fluticasone

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Cawston, Norfolk, United Kingdom, NR10 4FE
      • Optimum Patient Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: 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 Names: FP/SAL; Seretide® 125

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation rate	Where an exacerbation is defined as: (i) Asthma-related; Hospital attendance / admissions OR; Accident & Emergency (A&E) attendance OR (ii) Use of oral steroids.	One-year outcome period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation control (a composite proxy measure)	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	One-year outcome period
Treatment success 1	(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).	One-year outcome period
Asthma hospitalisations	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	One-year outcome period
Compliance with ICS/LABA therapy	Compliance calculation based on prescription refills and (where possible) compliance questionnaire data	One-year outcome period
Use of reliever medication	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.	One-year outcome period
Cost of therapeutic regimen.	Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year	One-year outcome period
Asthma-related / respiratory hospitalisations	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	one year outcome period
Oral Thrush	Identified as: (i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis	One-year outcome period

Collaborators and Investigators

• Sponsor: Research in Real-Life Ltd
• Collaborators: Chiesi Farmaceutici S.p.A.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: November 11, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (ESTIMATE): November 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Asthma; Combination therapy; Switch; ICS/LABA; Seretide; Fostair; Primary care management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Salmeterol Xinafoate; Beclomethasone; Formoterol Fumarate
• Other Study ID Numbers: 004/11