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

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Broncho-Vaxom; Drug: Placebo - Cap

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching placebo capsule	Drug: Placebo - Cap; Matching Placebo capsule administered
Experimental: Broncho-Vaxom; 1 capsule (3.5 mg) per day, administered over 9 months	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: Vaxoral; Imocur; Broncho-Munal; Ommunal; Paxoral

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events	measurement of vital signs, results of physical examinations, number and severity of adverse events	9 months

Collaborators and Investigators

• Sponsor: Vifor Pharma
• Investigators: Principal Investigator: Yves De Prost, MD, Hôpital Necker-Enfants Malades

Publications and helpful links

General Publications

• Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
• Wolkerstorfer A, de Waard van der Spek FB, Glazenburg EJ, Mulder PG, Oranje AP. Scoring the severity of atopic dermatitis: three item severity score as a rough system for daily practice and as a pre-screening tool for studies. Acta Derm Venereol. 1999 Sep;79(5):356-9. doi: 10.1080/000155599750010256.
• Williams HC, Burney PG, Hay RJ, Archer CB, Shipley MJ, Hunter JJ, Bingham EA, Finlay AY, Pembroke AC, Graham-Brown RA, et al. The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. I. Derivation of a minimum set of discriminators for atopic dermatitis. Br J Dermatol. 1994 Sep;131(3):383-96. doi: 10.1111/j.1365-2133.1994.tb08530.x.
• Hanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Broncho-Vaxom
• Other Study ID Numbers: BV-2002/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No