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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: OM-85 BV (Broncho-Vaxom); Drug: OM-85 BV (placebo)

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).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kec.oren
    • Ankara, Kec.oren, Turkey, 06380
      • Kecioren Education and Training Hospital
  • Keçiören
    • Ankara, Keçiören, Turkey, 06380
      • Kecioren Education and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: OM-85 BV (Broncho-Vaxom); 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months; Other Names: Bronchovaxom 3.5 mg capsule
Placebo Comparator: 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.	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; Other Names: Bronchovaxom 3.5 mg placebo capsule

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kecioren Education and Training Hospital

Publications and helpful links

General Publications

• Razi CH, Harmanci K, Abaci A, Ozdemir O, Hizli S, Renda R, Keskin F. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol. 2010 Oct;126(4):763-9. doi: 10.1016/j.jaci.2010.07.038.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: asthma; wheezing; childhood; OM-85 BV; Broncho-Vaxom
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Broncho-Vaxom
• Other Study ID Numbers: B100İEG0110001 - 2860