Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis

Study Overview
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Brief Summary
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The objective of this pilot double-blind study was to evaluate the efficacy and the safety of Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the evolution of the disease in children suffering from Atopic Dermatitis (AD).

Detailed Description
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Children outpatients of both sexes, aged 6 months to 7 years, with AD confirmed by Haniffin-Rajka or Williams et al, and an AD score (SCORAD) between 25 and 70 were included and followed for 9 months. Patients were randomized to receive either Broncho-Vaxom 1 capsule (3.5 mg) per day or the corresponding placebo over 9 months. Children under general corticotherapy within one month of study start, patients with immunodeficiency, patient's affected body surface area less than 15% or greater than 70% or with known allergy to desonide were excluded. Outcome measures were a comparisons between the two groups in the number of AD flares during the study after the first month of treatment. Secondary outcome measures were comparisons between the two groups based on SCORAD evolution, area of eczema, amount of corticoids used and parents/investigator assessments.

Official Title
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Multicentre, Randomised, Double Blind, Placebo-controlled Study of the Efficacy and Safety of Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Broncho-Vaxom
* Drug: Placebo - Cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female children aged 6 months to 7 years (in eighth year of life) Children with Atopic Dermatitis (Hanifin-Rajka or Williams et al criteria) with affected body surface area ≥15% and ≤ 70% 25 ≤ SCORAD ≤ 70 Written informed consent obtained from the parents/legal Guardian (and the child if applicable) Exclusion Criteria: Children under general corticotherapy within one month of study start Children with immunodeficiency Children with malignant disease Children with SCORAD<25 or >70 Children with affected body surface area < 15% or >70% Children with autoimmune disease Children under immunosuppressive or immunostimulating therapy within 1 month of study start Children whose parents or Guardians are unable to comply with the requirements of the protocol e.g.completion of patient's diary card Children with a known allergy or previous intolerance or known hypersensitivity to the trial drug or any of the corticoids used Participation in another clinical trial and/or treatment with an experimental drug within 3 months of study start and during present trial

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Broncho-Vaxom<br>1 capsule (3.5 mg) per day, administered over 9 months | Drug: Broncho-Vaxom<br>* BV is an orally administered immunostimulating preparation, which consists of a lyophilised bacterial extract prepared from 8 bacterial species (Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis)<br>* Other names: Vaxoral;|
| Placebo Comparator: Placebo<br>Matching placebo capsule | Drug: Placebo - Cap<br>* Matching Placebo capsule administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Atopic Dermatitis (AD) flares over 9 months of treatment | Comparison between experimental and Placebo arms in the number of AD flares | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD Evolution over 9 months of treatment | Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment | 9 months | 
| Area of eczema involvement | Comparison between experimental and Placebo arms in eczema involvement by measurement and recording of total body surface area affected at 3 monthly intervals as compared with baseline | 9 months | 
| Amount of corticosteroids used | Comparison between experimental and Placebo arms in amount of corticosteroids used | 9 months |