AsthmaPhase 4NCT00733226
Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing
A Phase 4 study testing OM-85 BV (Broncho-Vaxom) in people with Asthma, run by Kecioren Education and Training Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- OM-85 BV (Broncho-Vaxom)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Aug 2007to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6 months
- Children with asthma who had at least 3 wheezing attacks in the last 6 months
Who cannot join
- Chronic lung disease
- Immun deficiency
- Malabsorption
- Anatomic abnormalities of the respiratory tract
- Gastroesophageal reflux disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kecioren Education and Training Hospital
Ankara, Kec.oren, 06380
Keçiören Education and Training Hospital
Ankara, Keçiören, 06380
About this study
Official title: Phase IV Study of Effect of OM-85 BV (Broncho-Vaxom) on Wheezing Related Morbidity in Children With Recurrent Wheezing
The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.
Read the detailed description
Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.
Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.
Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.
Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).
- Conditions
- Asthma
- Being tested
- OM-85 BV (Broncho-Vaxom), OM-85 BV (placebo)
- Keywords
- wheezing, asthma, childhood, OM-85 BV, Broncho-Vaxom
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM-85 BV (Broncho-Vaxom)Drug
Also called Bronchovaxom 3.5 mg capsule
3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months
OM-85 BV (placebo)Drug
Also called Bronchovaxom 3.5 mg placebo capsule
3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 Broncho-Vaxom | Active comparator | The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. Receives: Drug: OM-85 BV (Broncho-Vaxom) |
| 2 (Placebo OM-85 BV) | Placebo comparator | The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. Receives: Drug: OM-85 BV (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Rate of Wheezing Attacks
Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.
Measured: 12 months
Secondary outcomes (6)
Mean Duration (in Day) of Wheezing Attacks Per Patient
Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.
Measured: 12 months
Number of Common Cold
All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.
This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial.
Measured: 12 months
Number of Wheezing Attacks That Required Systemic Steroid Therapy
All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.
At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group.
Measured: 12 months
Number of Hospitalizations
During the study period of 12 months all hospitalizations for wheezing attacks were recorded.
Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.
This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial.
Measured: 12 months
Duration of Hospitalization/Per Patient
Over the 12 months of the study we calculated mean duration of hospitalization/per patients.
Measured: 12 months
Effect of OM-85 BV on Cytokine Levels
Cytokine levels were not measured during the trial because of unavailability of laboratory resources.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cem Hasan Razi, Kecioren Education and Training Hospital
- Investigators
- C H RAZI, MD, Study director, Kecioren Education and Training HospitalC H Razi, MD, Principal investigator, Kecioren Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733226
- Sponsor's protocol ID
- B100İEG0110001 - 2860
- Status last verified
- Jul 2014
- First submitted
- 11 Aug 2008
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Razi CH, Harmanci K, Abaci A, Ozdemir O, Hizli S, Renda R, Keskin F. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol. 2010 Oct;126(4):763-9. doi: 10.1016/j.jaci.2010.07.038.
PubMed 20920766
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Effect of OM-85 BV (Broncho-Vaxom) on Wheezing Related Morbidity in Children With Recurrent Wheezing
- ClinicalTrials.gov ID
- NCT00733226
- Acronym / sponsor ID
- B100İEG0110001 - 2860
- Conditions
- Asthma
- Keywords
- wheezing, asthma, childhood, OM-85 BV, Broncho-Vaxom
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Posted 16 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.
Detailed description
Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.
Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.
Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.
Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Broncho-Vaxom | Active comparator | Drug: OM-85 BV (Broncho-Vaxom)The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. |
| 2 (Placebo OM-85 BV) | Placebo comparator | Drug: OM-85 BV (placebo)The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6 months
- Children with asthma who had at least 3 wheezing attacks in the last 6 months
Key exclusion criteria (5 listed)
- Chronic lung disease
- Immun deficiency
- Malabsorption
- Anatomic abnormalities of the respiratory tract
- Gastroesophageal reflux disease
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 |
|---|---|---|
| OM-85 BV (Broncho-Vaxom)Also: Bronchovaxom 3.5 mg capsule3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months | Drug | 1 Broncho-Vaxom |
| OM-85 BV (placebo)Also: Bronchovaxom 3.5 mg placebo capsule3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months | Drug | 2 (Placebo OM-85 BV) |
Primary outcome
Mean Rate of Wheezing Attacks
Time frame: 12 months
Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.
6 secondary outcomes
Mean Duration (in Day) of Wheezing Attacks Per Patient
Time frame: 12 months
Number of Common Cold
Time frame: 12 months
Number of Wheezing Attacks That Required Systemic Steroid Therapy
Time frame: 12 months
Number of Hospitalizations
Time frame: 12 months
Duration of Hospitalization/Per Patient
Time frame: 12 months
Effect of OM-85 BV on Cytokine Levels
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20920766Razi CH, Harmanci K, Abaci A, Ozdemir O, Hizli S, Renda R, Keskin F. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol. 2010 Oct;126(4):763-9. doi: 10.1016/j.jaci.2010.07.038.
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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.
C H RAZI, MD study director
Kecioren Education and Training Hospital
C H Razi, MD principal investigator
Kecioren Education and Training Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OM-85 BV (Broncho-Vaxom) in people with Asthma, run by Kecioren Education and Training Hospital at 2 sites in Turkey (Türkiye).
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 2 inclusion and 5 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Rate of Wheezing Attacks (time frame: 12 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 NCT00733226, which also lists 1 linked publication.
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 16 Jul 2014.