Montelukast for Early Life Wheezing
Condition: Lung Diseases; Asthma
MeSH terms: Lung Diseases; Respiratory Sounds
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine the effects of montelukast on the duration of wheezing in children
      12 months to 3 years of age who visit a physician for care of a wheezing illness. Only
      patients from the Ankara area of Hacettepe University Medical Center in Turkey will be
      included in this study.
    

Detailed description: 
      BACKGROUND:

      Asthma has a large impact on the children of our society. It is among the most common chronic
      diseases of childhood and is the leading cause of absenteeism from school. It is unknown as
      to why more children are having recurrent episodes of wheezing and why some children have
      asthma while others do not. There is increasing evidence that differences in innate immune
      responses among children can determine which child will have recurrent wheezing and asthma.
      While many studies have focused on the factors that initiate innate immune responses, there
      are relatively few studies of the downstream factors that cause abnormal airway responses.
      There is evidence that eicosanoid mediators are part of the innate immune response and can
      function as its effector arm for allergic responses. The ability of leukotrienes and
      prostaglandins to produce central features of the asthma phenotype is well described and
      there is emerging evidence that lipoxins facilitate restoration of allergic changes in the
      airways. This study will test the hypothesis that the balance of airway eicosanoid expression
      during early-life wheezing illness and the genetically determined capacity to respond will
      predict recurrent wheezing. Moreover, an intervention to restore a more normal tissue
      response to this imbalance will reduce symptoms of early-life wheezing and subsequent
      recurrent episodes.

      DESIGN NARRATIVE:

      This will be a prospective, double-blind, randomized, placebo-controlled, parallel-group
      study of the effects of montelukast on the duration of wheezing in children 12 months to 3
      years of age who are under the care of a physician for a wheezing illness. Study treatment
      will be given for 56 days. Participants who are 2 to 3 years old will receive either 5-mg
      montelukast tablets or matching placebo. Participants who are 12 months to 2 years old will
      receive 4-mg montelukast granules or matching placebo. The primary outcome parameter of this
      study will be the number of days that the infant is observed to be free of wheezing by the
      primary caregiver. The secondary outcome parameters will be the number of wheezing episodes
      during the treatment period and the rate of recurrent wheezing during the follow-up period.
      The study, which is a consortium arrangement between the Brigham and Women's Hospital and the
      Hacettepe University Medical Center in Turkey, will recruit children only from the Ankara
      area of Hacettepe University Medical Center in Turkey.

      This study will be one of three, which include: 1) measuring the airway eicosanoid profiles
      of pediatric "wheezing" patients 3 months to 3 years old; 2) determining if genetic variants
      in eicosanoid metabolic and response pathways are associated with recurrent wheezing; and 3)
      determining how intervention with montelukast (singulair) affects symptoms and the rate of
      recurrent wheezing.
    

Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.; Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention