Efficacy of Inhaled Budesonide Along with Oral Montelukast Compared to Inhaled Budesonide Alone in Patients with Mild-to-Moderate Asthma

Background: Inhaled corticosteroids (ICS) are widely used either alone or in combination with other classes of drugs for treatment of asthma. Now-a-days leukotriene antagonists (LTRAs) have also emerged as an impor- tant drug in asthma management. Objective: To evaluate the efficacy of inhaled Budesonide along with oral Montelukast in compari- son to inhaled Budesonide alone in mild-to-moderate asthmatic patients. Study design: Single blind prospective study Main outcomes: Peak expiratory flow (PEF), Forced expiratory volume in 1st second (FEV1), Forced vital capacity (FVC), and Sputum eosinophils. Method: A single blind prospective study carried at tertiary care teaching hospital. 40 patients of bronchial asthma (Group A) meet- ing the inclusion criteria, received inhaled Budesonide 400 µg bid, 40 other bronchial asthma patients (Group B) received inhaled Budesonide 400 µg bid along with oral Montelukast 10 mg OD daily for 4-weeks. Patient parameters recorded before and after study period were PEF, FEV1, FVC, and sputum eosinophil count. Results: Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean FEV1, PEF, and FVC improved significantly (p<0.05) in the 4 weeks of treatment com- pared with baseline in both groups. Both groups showed statistically significant reduction in sputum eosinophil count also. Compared with Group 'A', Group 'B' showed significant improvement in FEV1 and significant reduction in sputum eosinophils, but improvement in PEF, FVC. Conclusion: This study shows that inhaled Budesonide along with oral Montelukast is more effective and well tolerated and provides greater improvements in asthma control compared to inhaled Budesonide alone.