The Efficacy and Tolerability of Inhaled Montelukast Plus Inhaled Mometasone Compared with Mometasone Alone in Patients with Chronic Asthma
Journal of Asthma, 06/03/2011
Philip G et al. – Inhaled montelukast plus inhaled mometasone was significantly more effective than placebo plus inhaled mometasone in improving FEV1, symptoms, asthma control, and blood eosinophil count.Methods
- This was an 8-week, multicenter, randomized, double-blind, placebo-controlled study comparing once-daily inhaled montelukast 1 mg plus inhaled mometasone 220 μ μg (delivered by separate dry powder inhalers) with placebo plus inhaled mometasone 220 μ μg.
- A total of 134 patients were randomized.
- Men and women aged 15--85 years with chronic asthma, forced expiratory volume in 1 second (FEV1) 50--80%% of the predicted value, and β β-agonist reversibility ≥ ≥12%% were eligible.
- Patients were required to meet a minimum symptom threshold while receiving open-label inhaled mometasone during a 3-week prestudy/run-in period.
- Patients received blinded (montelukast vs. placebo) treatment for 2 weeks, entered a 1-week washout period, then crossed over to the other treatment for 2 weeks.
- The primary endpoint was the average change from baseline in FEV1 over the 2-week treatment period.
- Secondary endpoints included daytime and nighttime symptom scores.
- Other endpoints included short-acting β β-agonist (SABA) use, asthma exacerbations, asthma control, peak expiratory flow (PEF), and blood eosinophil count.
- For the primary endpoint, change from baseline in FEV1, inhaled montelukast plus inhaled mometasone was significantly more effective than placebo plus inhaled mometasone (least squares mean 0.22 L vs. 0.17 L; p == .033 [two-sided at α α == 0.05]).
- Inhaled montelukast plus inhaled mometasone was also significantly more effective than placebo plus inhaled mometasone in improving daytime asthma symptom scores (p == .005) and nighttime asthma symptom scores (p == .015), increasing the percentage of days with asthma control (p == .004), decreasing the percentage of days with asthma exacerbations (p ≤ ≤ .001), and decreasing the blood eosinophil count (p == .013).
- Differences were not significant on AM or PM PEF or SABA use, although the latter approached significance (p == .073).
- Both treatments were well tolerated.