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

Kim, Chang-Keun; Callaway, Zak; Park, Jin-Sung; Nishimori, Hisashi; Ogino, Tikatoshi; Nagao, Mizuho; Fujisawa, Takao

This was a randomized, parallel, 3-group, open-label trial. Patients who met the enrollment criteria entered a 2-week run-in period, with short-acting beta2-agonists as needed. Participants were then randomly selected to join 1 of the 2 groups: the BIS group received budesonide inhalation suspension (BIS) 0.5 mg once daily for 12 weeks and the MONT group received montelukast 4 mg once daily (orally) for 12 weeks. BIS was administered via a SkyNeb (Medel, Milan, Italy) compressor and nebulizer with a mouthpiece (for older children) or face mask (for children 1-3 years old). Patients that were ineligible for the trial because randomization criteria 2) was not met, EDN < 53 ng/mL and/or negative specific IgE to HDM, yet had symptoms in the run-in period were invited to receive montelukast 4 mg once daily based on recommendation by the Japanese guideline. 14,15 They were observed for 12 weeks as exploratory purpose (OBS group). Parents/caregivers of all participants were instructed to record all symptoms and treatment times in an asthma diary. Patients were evaluated at 4-week intervals ( Fig. 1) in either a hospital or clinic to have their asthma diary checked and to determine whether a step-up in therapy was needed as per GINA and Japanese guidelines.