An observational study in Asthma, sponsored by Research in Real-Life Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-08.
Sponsored by Research in Real-Life Ltd · Observational
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.
4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 137 is close to the median of 150 across 993 observational studies indexed under Asthma.
Browse Asthma studies →Research in Real-Life Ltd is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Aged:
Evidence of asthma:
Baseline FP/SAL therapy:
Exclusion Criteria:
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
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
Also known as: FP/SAL; Seretide® 125
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Also known as: BDP/FOR; Fostair® 100/6
Exacerbation rate
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.
Time frame: One-year outcome period
Exacerbation control (a composite proxy measure)
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
Time frame: 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).
Time frame: One-year outcome period
Asthma hospitalisations
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
Time frame: One-year outcome period
Compliance with ICS/LABA therapy
Compliance calculation based on prescription refills and (where possible) compliance questionnaire data
Time frame: 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.
Time frame: 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
Time frame: One-year outcome period
Asthma-related / respiratory hospitalisations
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
Time frame: one year outcome period
Oral Thrush
Identified as: (i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis
Time frame: One-year outcome period
The record gives a start of Jan 2008, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Research in Real-Life Ltd