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

REACH Fostair vs Seretide - 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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: FP/SAL; Drug: BDP/FOR

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 194723

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: Non-Probability Sample

Study Population

All patients are diagnosed with asthma or COPD and aged between 18-80 years with all 61-80 year olds being non-smokers only

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BDP/FOR; Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose	Drug: FP/SAL; Other Names: Seretide®; Drug: BDP/FOR; Other Names: Fostair® 100/6
FP/SAL; Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose	Drug: FP/SAL; Other Names: Seretide®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbations : rate ratio	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation control	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.	1 year
Proxy asthma control + SABA	As above, but with an additional criterion that limits "controlled" patients to those who use ≤200mcg salbutamol daily	1 year
Treatment success	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).	1 year
Asthma Control (including SABA)	Defined as proxy asthma control (above) plus: Average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline	1 year
Hospitalisations	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	1 year
Medication possession ratio	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.	1 year

Collaborators and Investigators

• Sponsor: Research in Real-Life Ltd
• Collaborators: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: David Price, University of Aberdeen

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Estimate): July 25, 2013
• Last Update Submitted That Met QC Criteria: July 24, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Primary care; Observational; Asthma management; Real-world; Seretide; Fostair
• 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; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Sympathomimetics; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: R04312