ABSTRACT: 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.
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 FEV(1) 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 FEV(1) ≤ 70% predicted normal, FEV(1)/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.
Patients (N=247) were randomized to FSC MDI (FEV(1)% 49.3 ± 12.3, FEV(1)/FVC 50.5 ± 10.0) and FSC DISKUS (FEV(1)% 48.4 ± 11.0, FEV(1)/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 FEV(1) at endpoint was -2.0mL (95% CI -64mL, 59mL). Pre-dose FEV(1), 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.
This is the first study to demonstrate that FSC MDI has a similar efficacy and safety profile to FSC DISKUS in COPD patients.
The Open Respiratory Medicine Journal 01/2010; 4:86-91.