MedTrace Logo

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

NCT00733226 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-07-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Kecioren Education and Training Hospital

    lead OTHER

Principal Investigators

  • C H RAZI, MD · Kecioren Education and Training Hospital

  • C H Razi, MD · Kecioren Education and Training Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-09-30
Completion
2008-10-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00733226 on ClinicalTrials.gov