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

Completed

• Conditions: Asthma
• Interventions: Drug: Fixed-dose combination beclometasone dipropionate / formoterol; Drug: Fixed dose combination salmeterol / fluticasone

• Registration Number: NCT01242098
• Lead Sponsor: Research in Real-Life Ltd

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-11-11
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fostair switch cohort	Fixed-dose combination beclometasone dipropionate / formoterol	Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair
Seretide continuation cohort	Fixed dose combination salmeterol / fluticasone	Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide

Primary Outcome Measures

Name	Time	Method
Exacerbation rate	One-year outcome period	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

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

Trial Locations

Locations (1)

Optimum Patient Care; 🇬🇧 Cawston, Norfolk, United Kingdom