Trial | NCT03047954  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    179
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).
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.
Study Started
Jul 31
2003
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Feb 09
2017
Estimate

Drug Broncho-Vaxom

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

Drug Placebo - Cap

Matching Placebo capsule administered

Broncho-Vaxom Experimental

1 capsule (3.5 mg) per day, administered over 9 months

Placebo Placebo Comparator

Matching placebo capsule

Criteria 

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
No Results Posted