Abstract
Background and Objectives The addition of an inhaled long-acting ?2-agonist (LABA) to an inhaled corticosteroid (ICS) gives optimal control of asthma in most patients. The LABA salmeterol xinafoate (salmeterol) with inhaled corticosteroid (ICS) fluticasone propionate (fluticasone) and formoterol with budesonide are available as a combination product pMDI in a single aerosol inhaler. This study compared the efficacy and safety of commercially available salmeterol/fluticasone with formeterol/budesonide.
Materials and Methods Patients aged >12 years inclusive of either sex (N = 40) with persistent asthma as defined by NHLBI for >6 months prior to screening were included in the study. After a screening phase (1 week), eligible patients were enrolled in the study with 2 weeks run-in period. Eligible patients were randomized to receive either of the two treatment groups [HFA-propelled pMDI salmeterol/fluticasone (50/100 mcg) or HFApropelled formoterol/budesonide (6/100 mcg) pMDI] in a ratio of 1:1 for the 12-week treatment period. The primary objective was to demonstrate non-inferiority of salmeterol/ fluticasone vs. formoterol/budesonide, measured by mean pre-dose forced expiratory volume in the first second (FEV1), at week 12.
Results This study provides evidence for the primary efficacy endpoint that salmeterol/ fluticasone was statistically as well as clinically non-inferior to formoterol/budesonide in the treatment of patients with persistent asthma. This was supported by secondary endpoints which demonstrate that salmeterol/fluticasone appeared to be comparable to formoterol/budesonide in terms of efficacy for the secondary efficacy endpoints (morning PEFR, evening PEFR, diurnal variability of PEFR, daytime and night-time asthma symptoms score, average need for short-acting ?2-agonists, proportion of patients that required rescue medication, patients with nocturnal asthma, patients without asthma symptoms of score 0 and average number of days without asthma symptoms of score 0). Salmeterol/fluticasone was safe and well tolerated; and safety profile is comparable to
comparator formoterol/budesonide.
Conclusion The results of this study demonstrate that HFA formulations of salmeterol/ fluticasone and formoterol/budesonide are clinically interchangeable. Overall, the study indicates that HFA-propelled salmeterol/fluticasone (50/100 mcg) pMDI was safe, well tolerated and non-inferior in efficacy compared to HFA-propelled formoterol/budesonide
(6/100 mcg) pMDI.
Keywords
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