title: A randomized open-label comparative study of montelukast versus theophylline added to inhaled corticosteroid in asthmatic children.
abstract: BACKGROUND
  Inhaled corticosteroids (ICSs) are widely used in combination with other classes of drugs for treatment of childhood asthma. The efficacy and the safety of montelukast added to low-dose ICS therapy were compared with those of sustained-release theophylline added to low-dose ICS therapy in asthmatic children in the present study.
  
  
  METHODS
  Following the 2-week run-in period, 6-to 14-year old patients receiving treatment with ICSs were randomized to treatment for 4 weeks with either montelukast 5 mg once daily or sustained release theophylline 5-8 mg/kg (dry syrup) or 100-200 mg (tablet) twice daily. Patients also received a fixed dose of ICS throughout the run-in and treatment periods. The primary efficacy endpoint was the change from baseline in peak expiratory flow (PEF) at Week 2.
  
  
  RESULTS
  A significant increase in morning PEF was observed in the add-on montelukast group as compared with the add-on theophylline group at Week 2 (change from baseline of 22.8 L/minvs. 8.7 L/min; p = 0.041 for between-group difference) and at Week 4 (31.0 L/minvs. 9.8 L/min; p = 0.012). A significant increase in evening PEF was observed in the add-on montelukast group as compared with the add-on theophylline group at Week 4 (24.7 L/minvs. 8.7 L/min; p = 0.027). There were no significant differences between the treatment groups in incidences of clinical and laboratory adverse experiences.
  
  
  CONCLUSIONS
  The results indicate that montelukast added to low-dose ICS is an effective and safe option for the treatment of asthma in children.
authors.affiliation: Department of Pediatrics, Graduate School of Medicine, Gifu University, Gifu, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Kondo
authors.forename: Toshio
authors.initials: T
authors.lastname: Katsunuma
authors.forename: Yasuhei
authors.initials: Y
authors.lastname: Odajima
authors.forename: Akihiro
authors.initials: A
authors.lastname: Morikawa
mesh_terms: D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects; D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002648:Child; D003521:Cyclopropanes; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D013440:Sulfides; D013806:Theophylline / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000085:Acetates; D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D003692:Delayed-Action Preparations; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D013806:Theophylline; C093875:montelukast