for people ages 6 months to 72 months (full criteria)
at Oakland, California and other locations
study started
completion around



This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing

Official Title

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


This study is a 12-months phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of daily treatment with OM-85 compared to placebo, when given on top of standard of care treatment, in reducing wheezing/asthma like episodes (WEs) during the 6-month treatment period in children aged 6 months to 5 years with previous recurrent WEs.

Patients will be randomized in a 1:1 ratio to OM-85 or placebo. The study consists of screening period (Day -20 to Day -1), a treatment period of 6 months, and an observational period of 6 months without treatment. Thus, the total duration of the study for each patient will be 12 months (±10 days) + up to 20 days for screening.


Recurrent Wheezing, Wheezing Lower Respiratory Illness, Innate immune response, Type 1 immune response, Type 2 immune response, Bacterial lysate, Immunomodulation, EAGLE, Recurrence, Respiratory Sounds


You can join if…

Open to people ages 6 months to 72 months

Subjects who meet all the following criteria will be included in the study:

  • Children of either gender, aged between 6 and 72 months (5 years inclusive).
  • Children with recurrent wheezing:
    • For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including at least one that triggered an unscheduled physician visit, in the 12 months prior to enrollment.
    • For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR ≥2 WEs including at least one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy.
  • Up-to-date vaccination status as per applicable State Vaccination Requirements for school/day-care entry.
  • Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.

Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week.

You CAN'T join if...

  • Known anatomic alterations of the respiratory tract.
  • Wheezing documented to be caused by gastroesophageal reflux.
  • Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).
  • Any known autoimmune disease.
  • Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency).
  • Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities.
  • Children born prematurely i.e., before 34 weeks of gestational age.
  • Children with an abnormally low or high weight for their age and height, if this would not allow safe completion of the clinical study in the opinion of the investigator.
  • Any known neoplasia or malignancy.
  • Treatment with the following medications:
    • Systemic (intravenous or intramuscular) or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment.
    • Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment.
  • Any major surgery within the last 3 months prior to study enrollment.
  • Known allergy or previous intolerance to investigational drug.
  • Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
  • Other household members have previously been randomized in this clinical study.
  • Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
  • Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s).

    Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.


  • UCSF Benioff Children's Hospital Oakland Primary Care Clinic accepting new patients
    Oakland California 94618 United States
  • Kern Research Inc. accepting new patients
    Bakersfield California 93301 United States


accepting new patients
Start Date
Completion Date
OM Pharma SA
Phase 2 research study
Study Type
Expecting 288 study participants
Last Updated