A Phase 3 interventional study of Broncho-Vaxom and Placebo - Cap in Atopic Dermatitis, sponsored by Vifor Pharma. Completed. Open to participants aged 6 Months to 7 Years. Per ClinicalTrials.gov, last updated 2017-02-09.
Sponsored by Vifor Pharma · Phase 3, Interventional, and Prevention
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 179 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Vifor Pharma is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 capsule (3.5 mg) per day, administered over 9 months
Drug: Broncho-Vaxom
Matching placebo capsule
Drug: Placebo - Cap
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)
Also known as: Imocur, Broncho-Munal, Ommunal, Paxoral, Vaxoral
Matching Placebo capsule administered
Number of Atopic Dermatitis (AD) flares over 9 months of treatment
Comparison between experimental and Placebo arms in the number of AD flares
Time frame: 9 months
SCORAD Evolution over 9 months of treatment
Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment
Time frame: 9 months
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
Time frame: 9 months
Amount of corticosteroids used
Comparison between experimental and Placebo arms in amount of corticosteroids used
Time frame: 9 months
Incidence of treatment emergent adverse events
measurement of vital signs, results of physical examinations, number and severity of adverse events
Time frame: 9 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Vifor Pharma