A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

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 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

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent Wheezing; Wheezing Lower Respiratory Illness
• Intervention / Treatment: Drug: OM-85; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • University Hospital Geelong - Barwon Health
    • Melbourne, Victoria, Australia, 3052
      • The Royal Childrens Hospital
• Hungary
  • Borsod-Abauj Zemplen county
    • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
      • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6720
      • Aranyklinika Kft.
• Poland
  • Lesser Poland Voivodeship
    • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
      • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o.
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-879
      • NZOZ E-Vita
  • Łódź Voivodeship
    • Skierniewice, Łódź Voivodeship, Poland, 96-100
      • Velocity Skierniewice Sp. z o.o.
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
    • Phoenix, Arizona, United States, 85015
      • Arizona Medical Clinic
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Medical Center - University Campus
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital Research Institute
  • California
    • Bakersfield, California, United States, 93301
      • Kern Research Inc.
    • Foothill Ranch, California, United States, 92610
      • Hoag Health Center Foothill Ranch
    • Oakland, California, United States, 94618
      • UCSF Benioff Children's Hospital Oakland Primary Care Clinic
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
  • Colorado
    • Aurora, Colorado, United States, 80045-7106
      • Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics
  • Florida
    • Coral Gables, Florida, United States, 33134
      • BioMD Clinical Research
    • Cutler Bay, Florida, United States, 33157
      • American Research Institute, INC
    • Miami, Florida, United States, 33183
      • C & R Research Services USA. Inc
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Children's Health - Pediatrics
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Allergy & Asthma Specialists PSC
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research - Lafayette
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • New York
    • Binghamton, New York, United States, 13905
      • Velocity Clinical Research - Binghamton
    • Great Neck, New York, United States, 11021
      • Northwell Health/Division of Allergy & Immunology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals, The Univ of NC at Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma and Clinical Research Center
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, PC
  • Tennessee
    • Nashville, Tennessee, United States, 37821
      • Monroe Carell Jr. Children's Hospital
  • Texas
    • Houston, Texas, United States, 77071
      • La Providence Pediatrics Clinic
    • Houston, Texas, United States, 77008
      • Helios Clinical Research - Houston
    • Mansfield, Texas, United States, 76063
      • Prime Clinical Research Inc
    • San Antonio, Texas, United States, 78229
      • STAAMP Research
    • Tyler, Texas, United States, 75708-3154
      • The University of Texas Health Science Center at Tyler - Pulmonology
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-9988
      • University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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 (at current dose or higher).
• Up-to-date vaccination status as per applicable State or country 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.

Exclusion Criteria:

• 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 corticosteroids 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 or planned during the study duration.
• 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 and have not completed their 6-month treatment period.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OM-85; Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.	Drug: OM-85; OM-85 capsule (3.5mg) contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.
Placebo Comparator: Placebo; Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.	Drug: Placebo; Placebo capsule contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Wheezing/Asthma like episodes (WEs)	To assess the efficacy of OM-85 in reducing the rate of WEs compared to placebo during the 6-month Treatment period in children aged 6 months to 5 years with previous recurrent WEs.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of severe WEs	To assess the efficacy of OM-85 in reducing the rate of severe WEs compared to placebo during the 6-month Treatment period.	6 Months
Number of days with WEs	To assess the efficacy of OM-85 to decrease the cumulative number of days with WEs compared to placebo during the 6-month Treatment period.	6 Months
Rate of WEs and severe WEs	To assess the efficacy of OM-85 compared to placebo in reducing the rate of WEs and severe WEs during the 6-month Observational period.	From Month 6 up to Month 12
Duration in days of WEs and severe WEs	To assess the efficacy of OM-85 compared to placebo in reducing the duration of WEs and of severe WEs during the 6-month Treatment period and the 6-month Observational period.	12 Months
Time to first, second and third WE	To assess the efficacy of OM-85 compared to placebo to prolong the time to first, second, and third WE.	12 Months
Number of routine asthma treatment	To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The number of routine asthma treatment will be assessed.	12 Months
Duration of routine asthma treatment	To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The duration of routine asthma treatment will be assessed.	12 Months
Number of days with respiratory tract infection (RTIs) symptoms	To assess the efficacy of OM-85 compared to placebo in reducing the number of days with RTI symptoms during the 6-month treatment period and the 6-month observational period.	12 Months
Number of antibiotic cycles	To assess the efficacy of OM-85 compared to placebo in reducing the antibiotics treatment for an RTI during the 6-month treatment period and the 6-month observational period.	12 Months
Number of medical visits	To assess the efficacy of OM-85 compared to placebo in reducing the number of medical visits (hospitalizations, visits to emergency rooms, or to a physician/health care provider) due to respiratory events during the 6-month treatment period and the 6-month observational period.	12 Months
Number of days absent from daycare/school	To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.	12 Months
Number of patients with adverse events (AEs)	To assess the safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent WEs during the 6-month treatment period and the 6-month observational period.	12 Months
Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)	To assess the efficacy of OM-85 compared to placebo in reducing the severity of RTI symptoms during the 6-month treatment period and the 6-month observational period. RTI symptoms severity will be assessed based on the symptom evaluation in the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K), other relevant symptoms indicative of an RTI (e.g., headache, body aches), and tympanic temperature as recorded by patient's parents or legally authorized representative (LAR). Severity of symptoms will be determined by using the following definitions: child does not have this = absent (no sign/symptom evident); a little bad = mild (sign/symptom clearly present but easily tolerated); bad = moderate (definite awareness of sign/symptom that is bothersome but tolerable); and very bad = severe (sign/symptom that is hard to tolerate and causes interference with activities of daily life and/or sleeping).	12 Months
Time to treatment failure	To assess the efficacy of OM-85 compared to placebo to prolong time to treatment failure, during the whole study period.	12 Months
Number of WE requiring oral corticosteroid (OCS) treatment during 6-month treatment period	To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs compared to placebo during the 6-month Treatment period.	6 Months
Number of WE requiring OCS treatments during 6-month observational period	To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs vs. placebo during the 6-month observational period.	From Month 6 up to Month 12
Percentage of patients with recurrent wheezing	To assess the efficacy of OM-85 compared to placebo in reducing the percentage of patients with ≥1 WEs and ≥2 WEs during the 6-month treatment period and the 6-month observational period.	12 Months
Number of work days when parents/LAR had to miss work or had their productivity	To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.	12 Months

Collaborators and Investigators

• Sponsor: OM Pharma SA
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Immunomodulation; Innate immune response; Bacterial lysate; Type 2 immune response; Type 1 immune response; EAGLE
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiratory Sounds
• Other Study ID Numbers: BV-2020/09; 2024-511083-90-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No