Montelukast versus budesonide as a first line preventive therapy in mild persistent asthma in 2 to 18 y.

OBJECTIVES: To compare the efficacy of oral Montelukast and inhaled Budesonide as a first line preventive therapy in mild persistent asthma in age group 2-18 y.

METHODS: This prospective randomized controlled clinical study was conducted for 12 wk. Sixty patients of mild persistent asthma aged 2 to 18 y were randomly allocated to either oral Montelukast (n = 60) or inhaled Budesonide (n = 60) group. Outcomes measured were improvement in peak expiratory flow rate (PEFR), forced expiratory volume 1 s/forced vital capacity (FEV1/FVC), day time and night time symptoms and frequency of exacerbations and need to change medications.

RESULTS: There was significant improvement in PEFR, FEV1/FVC, day time and night time symptoms and frequency of exacerbations in both groups. However, more significant improvement in FEV1/FVC (CI 95 %, p = 0.029) and day time symptoms (CI 95 %, p = 0.002) was seen in Budesonide group compared to Montelukast group.

CONCLUSIONS: The present study suggests that oral Montelukast is not inferior to Budesonide in treatment of mild persistent asthma in 2 to 18 y children in terms of control of symptoms and improvement in pulmonary function tests over a 12 wk period. However, there was more significant improvement in day time symptoms, more significant increase in FEV1/FVC ratio and less exacerbation in patients receiving Budesonide compared to those receiving Montelukast. However, side effects due to long term use of steroids such as growth stunting and bone osteopenia should also be considered before recommending. Trial registered at CTRI no. REF/2012/09/004035.