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
Identifiers and Pagination:Year: 2010
First Page: 86
Last Page: 91
Publisher ID: TORMJ-4-86
Article History:Received Date: 25/2/2010
Revision Received Date: 17/4/2010
Acceptance Date: 6/7/2010
Electronic publication date: 7/08/2010
Collection year: 2010
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.
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.