NCT00733226

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

Phase IV Study of Effect of OM-85 BV (Broncho-Vaxom) on Wheezing Related Morbidity in Children With Recurrent Wheezing

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kecioren Education and Training Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	OM-85 BV (Broncho-Vaxom)	3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months
DRUG	OM-85 BV (placebo)	3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-08-13
• Last updated: 2014-07-16
• Results posted: 2010-08-16

Locations

2 sites across 1 country: Turkey (Türkiye)