Please use this identifier to cite or link to this item:
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: Van Noord, J. A.
Lill, H.
Carrillo Diaz, T. 
Greefhorst, A. P.
Davies, P.
UNESCO Clasification: 32 Ciencias médicas
3209 Farmacología
Keywords: Fluticasone
Peak Expiratory Flow
Beclomethasone, et al
Issue Date: 2001
Journal: Clinical Drug Investigation 
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.
ISSN: 1173-2563
DOI: 10.2165/00044011-200121040-00002
Source: Clinical Drug Investigation[ISSN 1173-2563],v. 21(4), p. 243-255
Appears in Collections:Artículos
Show full item record


checked on Aug 7, 2022

Page view(s)

checked on May 28, 2022

Google ScholarTM




Export metadata

Items in accedaCRIS are protected by copyright, with all rights reserved, unless otherwise indicated.