Atopic DermatitisPhase 3NCT03047954
Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis
A Phase 3 study testing Broncho-Vaxom in people with Atopic Dermatitis, run by Vifor Pharma.
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). Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Broncho-Vaxom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
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
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).
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Broncho-Vaxom, Placebo - Cap
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho-VaxomDrug
Also called Imocur, Broncho-Munal, Ommunal, Paxoral
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 - CapDrug
Matching Placebo capsule administered
| Study group | Role | What they receive |
|---|---|---|
| Broncho-Vaxom | Experimental | 1 capsule (3.5 mg) per day, administered over 9 months Receives: Drug: Broncho-Vaxom |
| Placebo | Placebo comparator | Matching placebo capsule Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Atopic Dermatitis (AD) flares over 9 months of treatment
Comparison between experimental and Placebo arms in the number of AD flares
Measured: 9 months
Secondary outcomes (3)
SCORAD Evolution over 9 months of treatment
Comparison between experimental and Placebo arms in SCORAD evolution over 9 months of treatment
Measured: 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
Measured: 9 months
Amount of corticosteroids used
Comparison between experimental and Placebo arms in amount of corticosteroids used
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJul 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves De Prost, MD, Principal investigator, Hopital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047954
- Sponsor's protocol ID
- BV-2002/1
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 7918015Wolkerstorfer 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.
PubMed 10494710Severity 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.
PubMed 8435513Hanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03047954
- Acronym / sponsor ID
- BV-2002/1
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broncho-Vaxom | Experimental | Drug: Broncho-Vaxom1 capsule (3.5 mg) per day, administered over 9 months |
| Placebo | Placebo comparator | Drug: Placebo - CapMatching placebo capsule |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broncho-VaxomAlso: Imocur, Broncho-Munal, Ommunal, PaxoralBV 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) | Drug | Broncho-Vaxom |
| Placebo - CapMatching Placebo capsule administered | Drug | Placebo |
Primary outcome
Number of Atopic Dermatitis (AD) flares over 9 months of treatment
Time frame: 9 months
Comparison between experimental and Placebo arms in the number of AD flares
3 secondary outcomes
SCORAD Evolution over 9 months of treatment
Time frame: 9 months
Area of eczema involvement
Time frame: 9 months
Amount of corticosteroids used
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Background: PubMed 7918015Williams 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.
- Background: PubMed 10494710Wolkerstorfer 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.
- Background: PubMed 8435513Severity 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.
- BackgroundHanifin JM, Rajka G. Acta Derm Venereol Suppl (Stockh) 1980; 92:44-7
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves De Prost, MD principal investigator
Hopital Necker-Enfants Malades
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Broncho-Vaxom in people with Atopic Dermatitis, run by Vifor Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Atopic Dermatitis (AD) flares over 9 months of treatment (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047954, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.