Safety and Efficacy of Fluticasone Propionate/SalmeterolHydrofluoroalkane 134a Metered-Dose-Inhaler Comparedwith Fluticasone Propionate/Salmeterol Diskus in Patientswith Chronic Obstructive Pulmonary Disease

摘要

Purpose: To provide information on the efficacy and safety of Fluticasone Propionate/SalmeterolHydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg (FSC MDI) and its comparable dose of FluticasonePropionate/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 treatmentresponses as compared with FSC DISKUS. The primary comparison of interest was non-inferiority between the FSC MDItreatment group and the FSC DISKUS treatment group assessed in terms of 2-hour post-dose FEV1 change from baselineat endpoint. The non-inferiority criterion bound was 75mL (lower confidence limit of -75mL). Inclusion criteria: Male orfemale aged ≥ 40, post-bronchodilator FEV1 ≤ 70% predicted normal, FEV1/FVC ≤ 70% and ≥ 10 pack years smokinghistory. Adverse events were recorded by patients throughout the study on daily diary cards. Adverse events werecollected 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 (FSCMDI– 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 theFSC DISKUS arm.Conclusion: This is the first study to demonstrate that FSC MDI has a similar efficacy and safety profile to FSC DISKUSin COPD patients.