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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Broncho-Vaxom; Drug: Placebo - Cap

• Registration Number: NCT03047954
• Lead Sponsor: Vifor Pharma

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.

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Broncho-Vaxom	Broncho-Vaxom	1 capsule (3.5 mg) per day, administered over 9 months
Placebo	Placebo - Cap	Matching placebo capsule

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SCORAD Evolution over 9 months of treatment	9 months	Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment
Area of eczema involvement	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
Amount of corticosteroids used	9 months	Comparison between experimental and Placebo arms in amount of corticosteroids used