Effects of oral montelukast on pulmonary function and clinical symptoms in acute asthma exacerbations: a randomized, double-blind, placebo-controlled trial.

Introduction: Montelukast is a leukotriene receptor antagonist that helps treat chronic asthma and allergic rhinitis by reducing inflammation and bronchoconstriction. However, oral montelukast's effectiveness in managing acute asthma attacks has yet to be completely identified.

Methods: This randomized, double-blind, placebo-controlled trial investigated the efficacy of oral montelukast in acute exacerbations of asthma. Seventy patients between 18 and 65 years of age with a primary diagnosis of asthma attack were included in the study and were randomly assigned to receive 10 mg of montelukast orally daily or placebo. Symptoms, signs, forced expiratory volume in 1 second (FEV1), and peak expiratory flow rate (PEFR) were evaluated.

Results: Our findings showed a statistically significant difference between montelukast and placebo regarding FEV₁ (78.05 ± 7.84 vs. 72.05 ± 12.00, P = 0.016), PEFR (322.86 ± 28.95 vs. 290.86 ± 44.21, P = 0.003), and wheezing (P = 0.022) on the fifth day of treatment. Additionally, FEV₁ and PEFR values were compared in two subgroups of patients, ICS users (ICSU) and non-ICS users (NICSU), in both the montelukast and placebo groups. In the montelukast group, while PEFR improved significantly for day 5 in both the ICSU (P = 0.007) and NICSU (P = 0.027) subgroups, FEV₁ only improved in the ICSU (P = 0.009) subgroup compared to placebo.

Conclusion: The present study demonstrated that oral montelukast administered in acute asthma exacerbation could lead to better values of PEFR and FEV₁ on pulmonary function and improvement of wheezing in terms of symptoms.