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Completed

NCT Number: NCT00733226

Effect of OM-85 BV 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kecioren Education and Training Hospital, Ankara, Kec.oren, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OM-85 BV (Broncho-Vaxom)

Drug

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

OM-85 BV (placebo)

Drug

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

Primary outcomes

  1. Mean Rate of Wheezing Attacks

    Time frame: 12 months

    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.

Secondary outcomes

  1. Mean Duration (in Day) of Wheezing Attacks Per Patient

    Time frame: 12 months

    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.

  2. Number of Common Cold

    Time frame: 12 months

    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.

  3. Number of Wheezing Attacks That Required Systemic Steroid Therapy

    Time frame: 12 months

    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.

  4. Number of Hospitalizations

    Time frame: 12 months

    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.

  5. Duration of Hospitalization/Per Patient

    Time frame: 12 months

    Over the 12 months of the study we calculated mean duration of hospitalization/per patients.

  6. Effect of OM-85 BV on Cytokine Levels

    Time frame: 6 months

    Cytokine levels were not measured during the trial because of unavailability of laboratory resources.

Sponsors and collaborators

Lead sponsor

Kecioren Education and Training Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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