Abstract
Background: Non-responding to standard doses of inhalational corticosteroids (ICS) remains a challenge in the management of asthma, requiring add-on therapy. Acebrophylline, a theophylline derivative, with multiple mechanisms of action and properties, could work as a suitable alternative to montelukast as an add-on therapy.

Aims and Objectives: The aim of this study was to compare the efficacy and safety of montelukast versus acebrophylline as an add-on therapy to ICS in the treatment of bronchial asthma.

Materials and Methods: One hundred bronchial asthma patients, fulfilling inclusion/exclusion criteria, were enrolled and randomized in a 1:1 ratio into two groups of 50 each to receive either oral montelukast 10 mg OD or oral acebrophylline 200 mg OD with budesonide. Inhaled salbutamol was permitted as rescue medication during acute exacerbations. Primary outcome measures were change in pulmonary function test (PFT) parameters and asthma control questionnaire (ACQ) scores at baseline and 12 weeks. Adverse events, if any were recorded.

Results: There was a statistically significant difference in the improvement of mean PFT parameters at the end of 12 weeks in the montelukast group (P < 0.001), but not in acebrophylline group (P = 0.253). Montelukast was more efficacious than acebrophylline in improving PFT parameters at 6 and 12 weeks. Both treatment modalities significantly improved ACQ score at 12 weeks (P < 0.001), the difference between two groups was not statistically significant (1.4 ± 0.53 in Group A vs. 1.32 ± 0.44 in Group B, P = 0.436). No significant adverse effects were seen in both groups.

Conclusion: Montelukast, with low-dose ICS, had better efficacy over acebrophylline. Both montelukast and acebrophylline improved the quality of life in mild-to-moderate persistent asthma patients by decreasing nocturnal symptoms and the need for rescue medications.

Key words: Montelukast; Acebrophylline; Bronchial Asthma; Corticosteroids