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Completed

NCT Number: NCT03047954

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

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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Broncho-Vaxom

Drug

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)

Other names: Imocur, Broncho-Munal, Ommunal, Paxoral, Vaxoral

Placebo - Cap

Drug

Matching Placebo capsule administered

Primary outcomes

  1. Number of Atopic Dermatitis (AD) flares over 9 months of treatment

    Time frame: 9 months

    Comparison between experimental and Placebo arms in the number of AD flares

Secondary outcomes

  1. SCORAD Evolution over 9 months of treatment

    Time frame: 9 months

    Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment

  2. Area of eczema involvement

    Time frame: 9 months

    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

  3. Amount of corticosteroids used

    Time frame: 9 months

    Comparison between experimental and Placebo arms in amount of corticosteroids used

Other outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: 9 months

    measurement of vital signs, results of physical examinations, number and severity of adverse events

Sponsors and collaborators

Lead sponsor

Vifor Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Feb 9, 2017
Registry last updated
Feb 9, 2017

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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