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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: OM-85 BV (Broncho-Vaxom)
* Drug: OM-85 BV (placebo)


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Chronic lung disease Immun deficiency Malabsorption Anatomic abnormalities of the respiratory tract Gastroesophageal reflux disease

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Broncho-Vaxom<br>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. | Drug: OM-85 BV (Broncho-Vaxom)<br>* 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months<br>* Other names: Bronchovaxom 3.5 mg capsule;|
| Placebo Comparator: 2 (Placebo OM-85 BV)<br>The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. | Drug: OM-85 BV (placebo)<br>* 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months<br>* Other names: Bronchovaxom 3.5 mg placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Rate of Wheezing Attacks | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Duration (in Day) of Wheezing Attacks Per Patient | 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. | 12 months | 
| Number of Common Cold | 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. | 12 months | 
| Number of Wheezing Attacks That Required Systemic Steroid Therapy | 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. | 12 months | 
| Number of Hospitalizations | 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. | 12 months | 
| Duration of Hospitalization/Per Patient | Over the 12 months of the study we calculated mean duration of hospitalization/per patients. | 12 months | 
| Effect of OM-85 BV on Cytokine Levels | Cytokine levels were not measured during the trial because of unavailability of laboratory resources. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheezing, asthma, childhood, OM-85 BV, Broncho-Vaxom