RESEARCH ARTICLE


Safety and Efficacy of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler Compared with Fluticasone Propionate/Salmeterol Diskus in Patients with Chronic Obstructive Pulmonary Disease



Andras Koser1 , Jan Westerman2 , Sanjay Sharma3 , Amanda Emmett3 , Glenn D. Crater* , 3
1 Greenville Pharmaceutical Research, Greenville, SC 864-770-0890, USA
2 Jasper Summit Research, LLC, 1280 Summit Drive Jasper, AL 35501, USA
3 Respiratory Medicines Development Center, GlaxoSmithKline, 5 Moore Drive Research Triangle Park, NC 27709, USA


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© Koser et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Respiratory Medicines Development Center, GlaxoSmithKline, 5 Moore Drive Research Triangle Park, NC 27709, USA; Tel: 919 483 7185; E-mail: glenn.d.crater@gsk.com


Abstract

Purpose: To provide information on the efficacy and safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg (FSC MDI) and its comparable dose of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC DISKUS) in patients with COPD.

Methods: This multicenter, randomized, double-blind, 12 week study was designed to evaluate FSC MDI treatment responses as compared with FSC DISKUS. The primary comparison of interest was non-inferiority between the FSC MDI treatment group and the FSC DISKUS treatment group assessed in terms of 2-hour post-dose FEV1 change from baseline at endpoint. The non-inferiority criterion bound was 75mL (lower confidence limit of -75mL). Inclusion criteria: Male or female aged ≥ 40, post-bronchodilator FEV1 ≤ 70% predicted normal, FEV1/FVC ≤ 70% and ≥ 10 pack years smoking history. Adverse events were recorded by patients throughout the study on daily diary cards. Adverse events were collected in eCRFs at all clinic visits and during a final follow-up phone call.

Results: Patients (N=247) were randomized to FSC MDI (FEV1% 49.3 + 12.3, FEV1/FVC 50.5 + 10.0) and FSC DISKUS (FEV1% 48.4 + 11.0, FEV1/FVC 50.3 + 10.3). From an ANCOVA model the least squares (LS) mean difference (FSC MDI– FSC DISKUS) for the 2-hour post dose FEV1 at endpoint was -2.0mL (95% CI -64mL, 59mL). Pre-dose FEV1, FVC, PEF, and albuterol use were also similar between the two formulations. The most common adverse events (AE) during treatment were headache (8% and 6% of patients), nasopharyngitis (4% and 6%), cough (3% and 4%), and sinusitis (2% and 5%) for FSC MDI and FSC DISKUS, respectively. Pneumonia was recorded as an AE for 2 (2%) patients in the FSC DISKUS arm.

Conclusion: This is the first study to demonstrate that FSC MDI has a similar efficacy and safety profile to FSC DISKUS in COPD patients.

Keywords: Chronic Obstructive Pulmonary Disease (COPD), Fluticasone Propionate/Salmeterol (FSC) DISKUS, HFA, Inhaled Corticosteroid..