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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Broncho-Vaxom
Placebo - Cap
Sponsored by
Vifor Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atopic Dermatitis

Eligibility Criteria

6 Months - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Broncho-Vaxom

    Placebo

    Arm Description

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

    Matching placebo capsule

    Outcomes

    Primary Outcome Measures

    Number of Atopic Dermatitis (AD) flares over 9 months of treatment
    Comparison between experimental and Placebo arms in the number of AD flares

    Secondary Outcome Measures

    SCORAD Evolution over 9 months of treatment
    Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment
    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
    Amount of corticosteroids used
    Comparison between experimental and Placebo arms in amount of corticosteroids used

    Full Information

    First Posted
    January 13, 2017
    Last Updated
    February 7, 2017
    Sponsor
    Vifor Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03047954
    Brief Title
    Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vifor Pharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    179 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Broncho-Vaxom
    Arm Type
    Experimental
    Arm Description
    1 capsule (3.5 mg) per day, administered over 9 months
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Matching placebo capsule
    Intervention Type
    Drug
    Intervention Name(s)
    Broncho-Vaxom
    Other Intervention Name(s)
    Imocur, Broncho-Munal, Ommunal, Paxoral, Vaxoral
    Intervention Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo - Cap
    Intervention Description
    Matching Placebo capsule administered
    Primary Outcome Measure Information:
    Title
    Number of Atopic Dermatitis (AD) flares over 9 months of treatment
    Description
    Comparison between experimental and Placebo arms in the number of AD flares
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    SCORAD Evolution over 9 months of treatment
    Description
    Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment
    Time Frame
    9 months
    Title
    Area of eczema involvement
    Description
    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
    Time Frame
    9 months
    Title
    Amount of corticosteroids used
    Description
    Comparison between experimental and Placebo arms in amount of corticosteroids used
    Time Frame
    9 months
    Other Pre-specified Outcome Measures:
    Title
    Incidence of treatment emergent adverse events
    Description
    measurement of vital signs, results of physical examinations, number and severity of adverse events
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yves De Prost, MD
    Organizational Affiliation
    Hopital Necker-Enfants Malades
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    7918015
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10494710
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8435513
    Citation
    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.
    Results Reference
    background
    Citation
    Hanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7
    Results Reference
    background

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

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