A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo given in Children Aged 6 Months to 5 Years with Recurrent Wheezing

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511083-90-00

Acronym

BV-2020/09

Enrollment

Registered

2024-07-16

Start date

2024-10-03

Completion date

Unknown

Last updated

2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent wheezing

Brief summary

Rate of wheezing/asthma-like episodes (WEs) during the 6 months of the Treatment period, defined as the number of WEs experienced by a subject during the 6month Treatment period.

Detailed description

Rate of severe WEs during the 6month Treatment period., Number of WE requiring OCS treatment during the 6-month Treatment period., Number of days with wheezing/asthma-like symptoms during the 6month Treatment period., Safety, including AEs, SAEs, vital signs, and physical examination.

Interventions

DRUGBRONCHO-VAXOM Children Capsules placebo

DRUGBRONCHO-VAXOM

DRUG3

DRUG5mg

DRUGkapsułki

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Rate of wheezing/asthma-like episodes (WEs) during the 6 months of the Treatment period, defined as the number of WEs experienced by a subject during the 6month Treatment period.	—

Secondary

Measure	Time frame
Rate of severe WEs during the 6month Treatment period., Number of WE requiring OCS treatment during the 6-month Treatment period., Number of days with wheezing/asthma-like symptoms during the 6month Treatment period., Safety, including AEs, SAEs, vital signs, and physical examination.	—

Countries

Hungary, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026