Multicentre, Randomised, Double Blind, Placebo-controlled Study of the Efficacy and Safety of Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis
| Registry | NCT03047954 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 179 (Actual) |
| Sponsor | Vifor Pharma (Industry) |
| Conditions | Atopic Dermatitis |
| Interventions | Broncho-Vaxom, Placebo - Cap (Drug) |
| Dates | start 2003-07-01, primary completion 2006-12-01, completion 2006-12-01, first posted 2017-02-09, last updated 2017-02-09 |
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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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Broncho-Vaxom | Experimental | Drug: Broncho-Vaxom | 1 capsule (3.5 mg) per day, administered over 9 months |
| Placebo | Placebo comparator | Drug: Placebo - Cap | Matching placebo capsule |
Sex: All, ages: 6 Months to 7 Years
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