Background: Asthma guidelines allow antileukotriene medications to be used as an alternative to inhaled corticosteroids (ICSs) in second-step intensity therapy. The aim of this study was to determine whether asthma control can be maintained after reducing treatment from low-dose ICS to montelukast.
Methods: In this prospective, real-life 12-week trial, 84 young patients with asthma (7-18 years) controlled by low-dose ICS, had treatment switched to montelukast. Symptoms and PEF were monitored daily; exhaled nitric oxide (eNO) and spirometry every four weeks; sputum eosinophil (sEo) and bronchial hyperreactivity (BHR) assessed at the beginning and at the end of the study. The primary endpoint was number of patients discontinued from the study due to asthma exacerbations.
Results: Eleven patients (13.1%) were discontinued due to asthma exacerbations. At the beginning, patients with elevated percentage of sEo had increased risk of exacerbations (relative risk RR, 6.6; 95% CI, 1.2-35.6), as well as those with augmented BHR (RR, 4.24; 95% CI, 1.1-16.2) as compared to patients who completed the study. An intensification of symptoms and increased use of beta-adrenergics were observed during the last visit before exclusion from the study, but not changes in spirometry, PEF, and eNO. No change in clinical parameters, inflammatory markers or BHR was observed in patients remaining in the study.
Conclusions: After treatment switch from low-dose ICS to montelukast, asthma control was maintained in the majority of patients during the 12-week observation period. Sputum eosinophilia or BHR before the treatment switch was exacerbation risk factor.
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