In a randomized controlled trial 2 involving 196 adult and adolescent steroid-naïve asthmatics on SABAs only, the participants received either mometasone furoate (MF) 200 μg once daily in the evening or placebo for 12 weeks. In the MF group there was a significant improvement from baseline in FEV1 (0.43 l [16.8%] vs. 0.16 l [6%]; p<0.01), forced vital capacity(FVC), forced expiratory flow (FEF; 25% to 75%) and peak expiratory flow (PEF). MF was well tolerated. There were no significant differences in other efficacy variables of asthma symptom scores, in the time to worsening of asthma, in rescue albuterol use or nocturnal awakenings.
In another placebo-controlled RCT 3 involving 236 steroid-naïve adolescent and adult asthmatics, the patients in the treatment group were given either 200 μg or 400 μg of MF in the mornings. Both doses were well-tolerated. For FEV1, both doses showed superior efficacy compared with placebo (14.8% and 14.2% respectively vs. 2.5%). For morning PEF, the 400 μg was significantly superior to placebo, but not the 200 μg dose. Most of the secondary efficacy variables were significantly improved with both doses compared with placebo.
In another 12-week placebo-controlled RCT 4 involving 306 mild to moderate asthmatic subjects on inhaled SABAs only, the patients in the treatment group were given either 200 μg or 400 μg of MF once daily in the mornings or 200 μg twice daily. There was a significant improvement in mean change from baseline in FEV1 with both the 200 μg twice daily and 400 μg once daily doses compared with placebo (16.1% and 16.0% respectively vs. 5.5%), but the 200 μg once daily dosing did not show a significant difference from placebo. The secondary efficacy variables similarly improved significantly over placebo with a total daily dose of 400 μg.
Primary/Secondary Keywords