A prospective, open labeled, comparative study to assess the efficacy of montelukast as add on to β2-agonist and inhaled corticosteroid in patients of moderate persistent asthma

Background: Steroid, bronchodilator and the leukotriene receptor antagonist montelukast have demonstrated efficacy in children with mild persistent asthma, but comparative long-term studies in adult patient with moderate persistent asthma is needed. A randomized and prospective study was undertaken to find out the efficacy of montelukast as add on to β2-agonist and inhaled corticosteroids in patients of moderate persistent asthma. Methods: This was a continuous, longitudinal, prospective study carried out at a tertiary care teaching hospital. Newly diagnosed patients of moderate persistent asthma attending the chest out patient department (OPD) were enrolled. Group I was treated with salbutamol 200 mcg rotacap SOS and formoterol 6 mcg + budesonide 400 mcg rotacap BD. In addition to these medicines group II also received montelukast 10 mg OD. The patients were followed up every two months. Clinical examination and pulmonary function tests (PFT) were carried out at baseline and during each visit. Unpaired 't' test was used for statistical analysis. Results: Comparison of clinical symptoms revealed a better improvement in group II as compare to group I [cough - 83% vs. 33%; breathlessness - 75% vs. 33%; and wheezing - 83% vs. 78%] at the end of one year. A significantly better (p < 0.05) improvement in forced expiratory volume (FEV1) was also observed in group II. Conclusions: Treatment with montelukast leads to better improvement in clinical symptoms and PFT in the patients of moderate persistent asthma. [Int J Basic Clin Pharmacol 2012; 1(2.000): 91-101]