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Clinical Drug Investigation
Published in: Clinical Drug Investigation 4/2001

01-04-2001 | Clinical Use

Clinical Equivalence of a Salmeterol/Fluticasone Propionate Combination Product (50/500μg) Delivered via a Chlorofluorocarbon-Free Metered-Dose Inhaler with the Diskus™ in Patients with Moderate to Severe Asthma

Authors: Dr J. A. van Noord, H. Lill, T. Carrillo Diaz, A. P. Greefhorst, P. Davies

Published in: Clinical Drug Investigation | Issue 4/2001

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Abstract

Objective

To demonstrate equivalent efficacy and comparable tolerability of two inhaled combined formulations of salmeterol/fluticasone propionate (SALM/FP) 50/500μg twice daily in asthma patients.

Design and Setting

Multicentre, double-blind, parallel-group study.

Patients

Patients aged 12 to 82 years with moderate to severe asthma who were symptomatic on existing inhaled corticosteroid therapy.

Methods

176 patients were randomised to SALM/FP 50/500μg twice daily via a novel hydrofluoroalkane (HEA) metered-dose inhaler (MDI; 25/250μg per actuation), and 161 received the same dosage of SALM/FP via a dry powder Diskus™ inhaler (50/500μg) for 12 weeks. A third group of patients (n = 172) received the same dosage of steroid, FP 500μg twice daily, alone via a chlorofluorocarbon (CFC) MDI (250μg per actuation). The primary efficacy parameter was change in morning peak expiratory flow (PEF) over weeks 1 to 12.

Results

The SALM/FP MDI was clinically equivalent to the SALM/FP Diskus™ for the mean change in morning PEF over weeks 1 to 12 [adjusted mean increases 50 and 48 L/min, respectively; treatment difference −2 L/min; 95% confidence interval (CI):−11 to 7 L/min]. The SALM/FPMDI produced significantly greater improvements in morning PEF than the FPMDI (difference: −23 L/min; 95% CI: −32 to −14), with superiority for all secondary efficacy measures. All three treatments were well tolerated, with similar profiles and incidences of adverse events.

Conclusions

At a dosage of 50/500μg twice daily, the SALM/FP 25/250μg HFA MDI (two actuations twice daily) is clinically equivalent to the SALM/FP 50/500μg Diskus™ (one actuation twice daily). The availability of two formulations offers patients a choice of delivery systems when switching to combination therapy with SALM/FP.
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Metadata
Title
Clinical Equivalence of a Salmeterol/Fluticasone Propionate Combination Product (50/500μg) Delivered via a Chlorofluorocarbon-Free Metered-Dose Inhaler with the Diskus™ in Patients with Moderate to Severe Asthma
Authors
Dr J. A. van Noord
H. Lill
T. Carrillo Diaz
A. P. Greefhorst
P. Davies
Publication date
01-04-2001
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 4/2001
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.2165/00044011-200121040-00002

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