Conditions: Asthma
Keywords: wheezing asthma childhood OM-85 BV Broncho-Vaxom
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.

Detailed description:
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).

Arms:
arm 1: The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. arm 2: The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.

Interventions: intervention 1: OM-85 BV (Broncho-Vaxom) intervention 2: OM-85 BV (placebo)
Intervention descriptions: intervention 1: 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months intervention 2: 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months

Protocol document: