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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047954
• Other study ID #: BV-2002/1
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2017
• Last updated: February 7, 2017
• Start date: July 2003
• Est. completion date: December 2006

Study information

• Verified date: January 2017
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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)
• Placebo - Cap
Matching Placebo capsule administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vifor Inc.

References & Publications (4)

Hanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7

Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment emergent adverse events	measurement of vital signs, results of physical examinations, number and severity of adverse events	9 months
Primary	Number of Atopic Dermatitis (AD) flares over 9 months of treatment	Comparison between experimental and Placebo arms in the number of AD flares	9 months
Secondary	SCORAD Evolution over 9 months of treatment	Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment	9 months
Secondary	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	9 months
Secondary	Amount of corticosteroids used	Comparison between experimental and Placebo arms in amount of corticosteroids used	9 months