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

Asthma Clinical Trial

— REACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908075
• Other study ID #: R04312
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: July 24, 2013
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194723
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FP/SAL

• BDP/FOR

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Chiesi Farmaceutici S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Proxy asthma control + SABA	As above, but with an additional criterion that limits "controlled" patients to those who use =200mcg salbutamol daily	1 year	No
Secondary	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	No
Secondary	Asthma Control (including SABA)	Defined as proxy asthma control (above) plus: Average daily prescribed dose of =200mcg salubtamol / =500mcg terbutaline	1 year	No
Secondary	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	No
Secondary	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	No

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