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

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ClinicalTrials.gov Identifier: NCT03047954
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Vifor Inc.

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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Broncho-Vaxom Drug: Placebo - Cap Phase 3

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  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : July 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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:
  • Imocur
  • Broncho-Munal
  • Ommunal
  • Paxoral
  • Vaxoral

Placebo Comparator: Placebo
Matching placebo capsule
Drug: Placebo - Cap
Matching Placebo capsule administered




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   6 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047954


Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Yves De Prost, MD Hopital Necker-Enfants Malades

Publications:
Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT03047954     History of Changes
Other Study ID Numbers: BV-2002/1
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Broncho-Vaxom
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs