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

Asthma Clinical Trial

— Fos/Ser_switch  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242098
• Other study ID #: 004/11
• Status: Completed
• Phase: N/A
• First received: November 11, 2010
• Last updated: June 7, 2012
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fixed dose combination salmeterol / fluticasone
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
• Fixed-dose combination beclometasone dipropionate / formoterol
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy

Locations

Country	Name	City	State
United Kingdom	Optimum Patient Care	Cawston	Norfolk

Sponsors (2)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Compliance with ICS/LABA therapy	Compliance calculation based on prescription refills and (where possible) compliance questionnaire data	One-year outcome period	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Oral Thrush	Identified as: (i) Topical oral anti-fungal prescriptions, and / or; (ii) Coded for oral candidiasis	One-year outcome period	No

External Links

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