title: Do children with stable asthma benefit from addition of montelukast to inhaled corticosteroids: randomized, placebo controlled trial.
abstract: BACKGROUND
  To determine the effects of montelukast added to maintenance inhaled steroids (ICS) therapy during the school year in children with stable asthma on the ICS use, frequency of exacerbations, lung function, asthma symptoms, fractional exhaled nitric oxide (FeNO) level and exercise-induced bronchoconstriction (EIB).
  
  
  METHODS
  Seventy six asthmatic children aged 6-14 years, allergic to house dust mites were randomized to a double-blinded trial comparing montelukast therapy to a matching placebo. We studied following end-points: the reduction in the ICS dose, the frequency of exacerbations, lung function, asthma control test score, and the change from baseline in FEV1 during a standardized exercise treadmill challenge. ICS dose was adjusted in a stepwise fashion to determine the lowest dose necessary to control asthma symptoms.
  
  
  RESULTS
  We showed that children with baseline value of FeNO above 31 ppb and well controlled asthma symptoms on low doses of ICS, benefit the most from additive therapy with montelukast; their cumulative ICS dose is lower than in children treated with ICS only. Also, the addition of montelukast to regular treatment in asthmatic children resulted in a significant reduction in the frequency of exacerbations and EIB protection.
  
  
  CONCLUSIONS
  It is reasonable to add montelukast to ICS therapy in asthmatic children during the school year, to lower cumulative ICS dose in children with well controlled asthma symptoms, as well as to reduce number of exacerbations, and to achieve better control of EIB.
  
  
  BACKGROUND
  NCT01266772.
authors: Department of Pediatrics and Allergy, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland. Electronic address: alergol@kopernik.lodz.pl.
authors: Iwona
authors: I
authors: Stelmach
authors: Department of Pediatrics and Allergy, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
authors: Agata
authors: A
authors: Ożarek-Hanc
authors: Department of Pediatrics and Allergy, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
authors: Magdalena
authors: M
authors: Zaczeniuk
authors: Department of Social and Preventive Medicine, Medical University of Lodz, Lodz, Poland.
authors: Wlodzimierz
authors: W
authors: Stelmach
authors: Department of Pediatrics and Allergy, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
authors: Katarzyna
authors: K
authors: Smejda
authors: Department of Pediatrics and Allergy, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
authors: Pawel
authors: P
authors: Majak
authors: Department of Pediatrics and Allergy, Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
authors: Joanna
authors: J
authors: Jerzynska
authors: Department of Social and Preventive Medicine, Medical University of Lodz, Lodz, Poland; Institute of Dental Surgery, Faculty of Medicine and Dentistry, Medical University of Lodz, Poland.
authors: Janas
authors: J
authors: Anna
mesh_terms: D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000818:Animals; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy*; D002648:Child; D003521:Cyclopropanes; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005080:Exercise Test; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000150:complications; D008297:Male; D009569:Nitric Oxide / Q000378:metabolism; D039981:Pyroglyphidae; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D013440:Sulfides
chemical_list: D000085:Acetates; D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D009569:Nitric Oxide; C093875:montelukast
keywords: Childhood asthma; Exacerbations; Exercise-induced bronchoconstriction; ICS use; Montelukast