IngentaConnect Clinical Equivalence of a Salmeterol/Fluticasone Propionate Combi...

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 (HFA) 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/FP MDI produced significantly greater improvements in morning PEF than the FP MDI (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.

Keywords: Antiasthmatics, therapeutic use; Asthma, treatment; Salmeterol/fluticasone propionate, therapeutic use

Document Type: Original article

Affiliations: 1: Atrium Hospital, Heerlen, The Netherlands 2: Tartu University Lung Clinic, Tartu, Estonia 3: Servicio de Alergia, Hospital de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria, Spain 4: Geerdinksweg, Hengelo, The Netherlands 5: Respiratory Therapeutic Development, Glaxo Wellcome Research and Development, Uxbridge, England

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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