BEAR Study
Research type
Research Study
Full title
A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years with Wheezing Lower Respiratory Illness
IRAS ID
1005881
Contact name
Lorenz Lehr
Contact email
Sponsor organisation
OM Pharma SA
Eudract number
2022-000886-42
Clinicaltrials.gov Identifier
Research summary
The purpose of the BEAR study is to assess if the study drug is safe and efficacious in preventing infections involving the respiratory system (nose, throat, and lungs).
There has been significant clinical experience with the study drug. The study drug was first approved in Switzerland in 1979 and subsequentially was approved and made available in many countries worldwide for the prophylaxis of recurrent respiratory tract infections in adults and children. As of 31 December 2020, approximately 122 million patients (approximately 50% children and 50% adults) have received the study drug across the globe.
Although the effectiveness of the study drug is established for recurrent respiratory tract infections, The sponsor wants to confirm its short-term treatment efficacy and evaluate its long-term treatment effects in children aged 6 months to 5 years with wheezing lower respiratory illness.
To assess the effectiveness, the sponsor needs to compare the study drug with a placebo which is a capsule that looks identical to the study drug but contains no active medication. The term “study medications” will be used when referring to both OM-85 and/or placebo and “study drug” when referring only to OM-85.
Approximately 426 participants are expected to take part in the study at approximately 30 study sites from different regions of Europe.
This study is being sponsored by OM Pharma SA (Sponsor).
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/LO/0576
Date of REC Opinion
15 Nov 2022
REC opinion
Further Information Favourable Opinion