Clinical trial NCT03047954: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 179
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Atopic Dermatitis (AD) flares over 9 months of treatment
timeFrame: 9 months
Secondary outcomes:
measure: SCORAD Evolution over 9 months of treatment
timeFrame: 9 months
measure: Area of eczema involvement
timeFrame: 9 months
measure: Amount of corticosteroids used
timeFrame: 9 months
Other outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 9 months
Locations:
Study officials:
affiliation: Hopital Necker-Enfants Malades
name: Yves De Prost, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Hanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7