Montelukast Reduces Serum Levels of Eosinophil-Derived Neurotoxin in Preschool Asthma

Montelukast Reduces Serum Levels of Eosinophil-Derived Neurotoxin in Preschool Asthma

Purpose: Several markers for eosinophilic inflammation have been proposed to predictresponse to asthma treatment. However, definitive criteria for treatment decisions have notyet been established. We investigate a potentially useful relatively non-invasive biomarker,eosinophil-derived neurotoxin (EDN), to predict favorable responses to budesonide ormontelukast, common treatment for children with asthma. Methods: Young children (1 to 6 years old) were enrolled in this randomized, parallel,2-group, open-label trial. Criteria for eligibility included: 1) being symptomatic during therun-in period; and 2) having a serum EDN (sEDN) level ≥ 53 ng/mL, with positive specificimmunoglobulin E to house dust mite. Eligible patients were randomly placed into 2 groups:the BIS group received budesonide inhalation suspension (BIS) 0.5 mg once daily; the MONTgroup received montelukast 4 mg once daily. Ineligible patients were invited to receivemontelukast 4 mg once daily (OBS group). Treatment period was 12 weeks. Results: Asthma control days increased significantly in the BIS and MONT groups (P < 0.000)over the 12-week study period. There was no significant change in sEDN in the BIS group butthere was a significant decrease in the MONT group (P < 0.000). Patients in the OBS groupwith high EDN levels (> 53 ng/mL) showed a significant decrease due to MONT treatment(P = 0.023). Rescue medication usage significantly decreased in the BIS and MONT groups(P < 0.000). Conclusions: EDN is a useful relatively non-invasive biomarker for predicting responses tomontelukast and budesonide treatment of preschool children with beta2-agonist responsiverecurrent wheeze and multiple-trigger wheeze (Trial registry at UMIN Clinical Trials Registry,UMIN000008335).

Purpose: Several markers for eosinophilic inflammation have been proposed to predictresponse to asthma treatment. However, definitive criteria for treatment decisions have notyet been established. We investigate a potentially useful relatively non-invasive biomarker,eosinophil-derived neurotoxin (EDN), to predict favorable responses to budesonide ormontelukast, common treatment for children with asthma. Methods: Young children (1 to 6 years old) were enrolled in this randomized, parallel,2-group, open-label trial. Criteria for eligibility included: 1) being symptomatic during therun-in period; and 2) having a serum EDN (sEDN) level ≥ 53 ng/mL, with positive specificimmunoglobulin E to house dust mite. Eligible patients were randomly placed into 2 groups:the BIS group received budesonide inhalation suspension (BIS) 0.5 mg once daily; the MONTgroup received montelukast 4 mg once daily. Ineligible patients were invited to receivemontelukast 4 mg once daily (OBS group). Treatment period was 12 weeks. Results: Asthma control days increased significantly in the BIS and MONT groups (P < 0.000)over the 12-week study period. There was no significant change in sEDN in the BIS group butthere was a significant decrease in the MONT group (P < 0.000). Patients in the OBS groupwith high EDN levels (> 53 ng/mL) showed a significant decrease due to MONT treatment(P = 0.023). Rescue medication usage significantly decreased in the BIS and MONT groups(P < 0.000). Conclusions: EDN is a useful relatively non-invasive biomarker for predicting responses tomontelukast and budesonide treatment of preschool children with beta2-agonist responsiverecurrent wheeze and multiple-trigger wheeze (Trial registry at UMIN Clinical Trials Registry,UMIN000008335).