Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing

• Mean Rate of Wheezing Attacks [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.
  
  

• Mean Duration (in Day) of Wheezing Attacks Per Patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.
  
  
• Number of Common Cold [ Time Frame: 12 months ] [ Designated as safety issue: No ]

  All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.

  This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial.

  
  
• Number of Wheezing Attacks That Required Systemic Steroid Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

  All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.

  At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group.

  
  
• Number of Hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

  During the study period of 12 months all hospitalizations for wheezing attacks were recorded.

  Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.

  This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial.

  
  
• Duration of Hospitalization/Per Patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Over the 12 months of the study we calculated mean duration of hospitalization/per patients.
  
  
• Effect of OM-85 BV on Cytokine Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Cytokine levels were not measured during the trial because of unavailability of laboratory resources.
  
  

Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.

Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.

Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.

Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).