At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 80 enrolled
Drug / intervention
OM-85 BV (Broncho-Vaxom) +1 moredrug
Likely dose
OM-85 BV (Broncho-Vaxom) 3.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase IV Study of Effect of OM-85 BV (Broncho-Vaxom) on Wheezing Related Morbidity in Children With Recurrent Wheezing
In Brief
A Phase 4 clinical trial evaluating OM-85 BV (Broncho-Vaxom) and OM-85 BV (placebo) for Asthma. Completed, enrolled 80 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesTurkey (Türkiye)
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedAug 2008
Primary CompletionSep 2008
Study CompletionOct 2008
TodayJul 2026
First PostedAug 13, 2008
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.9 years ago
Interventions
OM-85 BV (Broncho-Vaxom)drug
3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months
OM-85 BV (placebo)drug
3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months