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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

NCT05857930

Recurrent Wheezing Wheezing Lower Respiratory Illness

ACTIVE_NOT_RECRUITING PHASE2

Montelukast for Early Life Wheezing

NCT00115297

Lung Diseases Asthma

COMPLETED PHASE2/PHASE3

Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

NCT00733473

Asthma Acute Asthma

COMPLETED PHASE4

Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

NCT01734811

Bronchospasm; Bronchiolitis Bronchospasm; Bronchitis

COMPLETED PHASE3

Video Assisted Study of Salbutamol Response in Viral Wheezing

NCT06093152

Wheezing

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 Broncho-Vaxom

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.

Group Type ACTIVE_COMPARATOR

OM-85 BV (Broncho-Vaxom)

Intervention Type DRUG

3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months

2 (Placebo OM-85 BV)

The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.

Group Type PLACEBO_COMPARATOR

OM-85 BV (placebo)

Intervention Type DRUG

3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OM-85 BV (Broncho-Vaxom)

3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bronchovaxom 3.5 mg capsule Bronchovaxom 3.5 mg placebo capsule

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6 months
* Children with asthma who had at least 3 wheezing attacks in the last 6 months