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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733226
• Other study ID #: B100IEG0110001 - 2860
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: July 4, 2014
• Start date: August 2007
• Est. completion date: October 2008

Study information

• Verified date: July 2014
• Source: Kecioren Education and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• OM-85 BV (Broncho-Vaxom)
3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months
• 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

Locations

Country	Name	City	State
Turkey	Kecioren Education and Training Hospital	Ankara	Kec.oren
Turkey	Keçiören Education and Training Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Razi CH, Harmanci K, Abaci A, Özdemir 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Duration of Hospitalization/Per Patient	Over the 12 months of the study we calculated mean duration of hospitalization/per patients.	12 months	No
Secondary	Effect of OM-85 BV on Cytokine Levels	Cytokine levels were not measured during the trial because of unavailability of laboratory resources.	6 months	No