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

Kecioren Education and Training Hospital

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: OM-85 BV (placebo); Drug: OM-85 BV (Broncho-Vaxom)

Study type: Interventional

Funder types: Other

Identifiers

NCT00733226

B100İEG0110001 - 2860

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

1 Broncho-Vaxom

Active Comparator group

Description:

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.

Treatment:

Drug: OM-85 BV (Broncho-Vaxom)

2 (Placebo OM-85 BV)

Placebo Comparator group

Description:

The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.

Treatment:

Drug: OM-85 BV (placebo)