Abstract
BACKGROUND: The role of leukotriene receptor antagonist is well known in the management of chronic asthma, but their efficacy in acute exacerbation of asthma is unknown. The present study was done to evaluate the clinical efficacy of oral montelukast as an add on therapy to the usual standard therapy of acute attack of bronchial asthma. MATERIALS AND METHODS: A randomized single-blinded controlled study was conducted in a tertiary care teaching hospital. A total of 162 patients with age >18 years of acute exacerbations due to bronchial asthma were included in the study. The patients were randomized into two study and control groups. The study group patients received oral montelukast (10 mg) once daily for 2 weeks, while the control group received a placebo. All the patients received standard therapy according to GINA guidelines. Improvements in lung function tests, clinical symptoms, and relapse rates were monitored at baseline, 1 week, 2 weeks, and 4 weeks. Side effects profile was also monitored. RESULTS: A total of 160 patients were finally assessed. Seventy-eight patients belonged to study group and 82 in the control group. Baseline characteristics were similar and well matched in both groups. Mean age was 39.9 ± 15.8 years in the study group and 42.8 ± 12.8 in the control group and majority were female patients in both groups. At the end of 4 weeks, it was observed that the study group patients who received montelukast had better forced expiratory volume in 1 s (FEV1) improvement by 21% (0.21 L) as compared to the control group (P < 0.0033). It was also observed that there was a better improvement in peak expiratory flow rate (PEFR) at 2 weeks (0.4 L/s, 12%) and at 4 weeks (0.9 L/s, 23%) as compared to the control group (P < 0.0376 and P < 0.0003 respectively). There was no difference in forced vital capacity (FVC), FEV1/FVC ratio and relapse rates between the two groups. No serious adverse effects were observed during the study. CONCLUSIONS: In acute asthma exacerbations, the present study showed that additional administration of oral montelukast resulted in significantly higher FEV1at 4 weeks and PEFR at 2 weeks and 4 weeks as compared to the standard treatment alone. These findings should be confirmed by conducting a larger population-based clinical study.