Date Published: November 14, 2011
Publisher: BioMed Central
Author(s): AS Nayak, RA Nathan, EO Meltzer, SF Weinstein, H Nolte.
An important asthma therapy goal is to limit short-acting β2-agonist (SABA) rescue medication use. We evaluated the effect of mometasone furoate/formoterol (MF/F) combination therapy on SABA use with data from 3 phase III studies.
All studies enrolled subjects (≥12y) with persistent asthma not well controlled on inhaled corticosteroids (ICS): study 1 (n=746 subjects with moderate persistent asthma randomized to 26wk MF/F-100/10µg, MF-100µg, F-10µg, or placebo twice daily [BID]); study 2 (n=781 subjects with moderate persistent asthma randomized to 26wk MF/F-200/10µg, MF-200µg, F-10µg, or placebo BID); study 3 (n=728 subjects with severe persistent asthma randomized to 12wk MF/F-400/10µg, MF/F-200/10µg, or MF-400µg BID). All studies included a 2-3wk MF BID run-in: P04073 (100µg), P04334(200µg), P04431(400µg). Percentage of SABA-free days/nights was a predefined secondary endpoint in all studies.
In study 1, mean change in the percentage of SABA-free days/ nights from baseline period (day -7 to 1) to overall treatment period was significantly increased for MF/F-100/10µg (18%) vs F-10µg (10%) and placebo (0% P≤.003), and numerically increased for MF/F-100/10µg vs MF-100µg (14%). In study 2, change in SABA-free days/nights was significantly increased for MF/F-200/10µg (21%) vs MF-200µg (15%), F-10µg (11%), and placebo (5%; P≤.033). In study 3, change in SABA-free days/nights was significantly increased for MF/F-400/10µg and MF/F-200/10µg groups (25% increase for each) vs the MF-400µg group (13%; P<.001). MF/F treatment resulted in significant improvement in the frequency of SABA-free days/nights vs individual MF and/or F monotherapies in subjects with persistent asthma not well controlled on ICS therapy. Source: http://doi.org/10.1186/1710-1492-7-S2-A15