Comparative evaluation of moderate dose inhalational corticosteroid (ICS) fluticasone with the combination of low dose fluticasone and montelukast in moderate persistent bronchial asthma.

Background: Use of inhaled corticosteroids (ICS) are recommended in all grades of persistent asthma and once the symptoms are stabilized, “stepping down" of steroids is recommended to minimize their unwanted effects with the addition of a second medication with a complimentary mechanism of action. Aims & Objective: In our study a comparison of moderate dose ICS Fluticasone in “stepping down” strategy with combination of low dose Fluticasone with once-daily montelukast were assessed. Materials and Methods: 50 patients with moderate persistent asthma were randomly assigned in study. Initially stabilized on fluticasone propionate (FP) 250 μg twice daily, for four weeks, there after patients were given the medication as per the protocol Group-I (n=25)- fluticasone 250μg BD; Group-II (n=25)- fluticasone125 μg BD + Montelukast 10 mg in night. Patients were then followed up for 12 weeks. The primary efficacy variables were changes in FEV1%, PEFR%, ACS (asthma control symptom) score and asthma quality of life (QOL) score. Results: Changes in lung function at the end of study in Group-I and Group-II respectively as compared to 0 week (baseline) values, FEV1% value (p <0.05, p <0.05), PEFR% value (p <0.01, p <0.05), ACS score (p <0.01, p <0.05), AQOL score (p <0.05, p <0.05). ICS fluticasone 250 μg BD and low dose fluticasone 125 μg BD + Montelukast 10 mg in night are equally efficacious in improving lung functions, asthma symptoms and QOL. Montelukast group was more expensive with fewer adverse events. Conclusion: Moderate dose fluticasone did not show any benefit over combination of low dose fluticasone and Montelukast 10mg in night. Montelukast 10 mg in combination with low dose fluticasone can be an alternative in moderate persistent asthma.