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

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.

Results

  • 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.

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