Clinical trial NCT00733226: Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing
Official title: Phase IV Study of Effect of OM-85 BV (Broncho-Vaxom) on Wheezing Related Morbidity in Children With Recurrent Wheezing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: wheezing
asthma
childhood
OM-85 BV
Broncho-Vaxom
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean Rate of Wheezing Attacks
timeFrame: 12 months
Secondary outcomes:
measure: Mean Duration (in Day) of Wheezing Attacks Per Patient
timeFrame: 12 months
measure: Number of Common Cold
timeFrame: 12 months
measure: Number of Wheezing Attacks That Required Systemic Steroid Therapy
timeFrame: 12 months
measure: Number of Hospitalizations
timeFrame: 12 months
measure: Duration of Hospitalization/Per Patient
timeFrame: 12 months
measure: Effect of OM-85 BV on Cytokine Levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kecioren Education and Training Hospital
state: Kec.oren
city: Ankara
country: Turkey
facility: Keçiören Education and Training Hospital
state: Keçiören
Study officials:
affiliation: Kecioren Education and Training Hospital
name: C H RAZI, MD
role: STUDY_DIRECTOR
affiliation: Kecioren Education and Training Hospital
name: C H Razi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.