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

NCT05857930 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BV-2020/092024-511083-90-00
• Study Type: interventional
• Target: 296
• Locations: 4 countries
• Sites: 38

Brief Summary

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

Conditions

Wheezing Lower Respiratory Illness; Recurrent Wheezing

Keywords

Innate immune response; Type 1 immune response; Type 2 immune response; Bacterial lysate; Immunomodulation; EAGLE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Rate of severe WEs

  6 Months

• Number of WE requiring oral corticosteroid (OCS) treatment during 6-month treatment period

  6 Months

• Number of days with WEs

  6 Months

• Rate of WEs and severe WEs

  From Month 6 up to Month 12

• Number of WE requiring OCS treatments during 6-month observational period

  From Month 6 up to Month 12

Study Arms (2)

OM-85

EXPERIMENTAL

Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.

Drug: OM-85

Placebo

PLACEBO COMPARATOR

Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.

Drug: Placebo

Interventions

OM-85 DRUG

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.

OM-85

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 6 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• OM Pharma SA: lead

Study Sites (38)

Arizona Medical Clinic

Phoenix, Arizona, 85015, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

The University of Arizona Medical Center - University Campus

Tucson, Arizona, 85724, United States

Location

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

Location

Kern Research Inc.

Bakersfield, California, 93301, United States

Location

Hoag Health Center Foothill Ranch

Foothill Ranch, California, 92610, United States

Location

UCSF Benioff Children's Hospital Oakland Primary Care Clinic

Oakland, California, 94618, United States

Location

Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology

San Diego, California, 92123, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics

Aurora, Colorado, 80045-7106, United States

Location

BioMD Clinical Research

Coral Gables, Florida, 33134, United States

Location

American Research Institute, INC

Cutler Bay, Florida, 33157, United States

Location

C & R Research Services USA. Inc

Miami, Florida, 33183, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Riley Children's Health - Pediatrics

Indianapolis, Indiana, 46202, United States

Location

Allergy & Asthma Specialists PSC

Owensboro, Kentucky, 42301, United States

Location

Velocity Clinical Research - Lafayette

Lafayette, Louisiana, 70508, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Velocity Clinical Research - Binghamton

Binghamton, New York, 13905, United States

Location

Northwell Health/Division of Allergy & Immunology

Great Neck, New York, 11021, United States

Location

UNC Hospitals, The Univ of NC at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Cincinnati Children'S Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Monroe Carell Jr. Children's Hospital

Nashville, Tennessee, 37821, United States

Location

Helios Clinical Research - Houston

Houston, Texas, 77008, United States

Location

La Providence Pediatrics Clinic

Houston, Texas, 77071, United States

Location

Prime Clinical Research Inc

Mansfield, Texas, 76063, United States

Location

STAAMP Research

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center at Tyler - Pulmonology

Tyler, Texas, 75708-3154, United States

Location

University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine

Madison, Wisconsin, 53792-9988, United States

Location

University Hospital Geelong - Barwon Health

Geelong, Victoria, 3220, Australia

Location

The Royal Childrens Hospital

Melbourne, Victoria, 3052, Australia

Location

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Aranyklinika Kft.

Szeged, Csongrád megye, 6720, Hungary

Location

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o.

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

NZOZ E-Vita

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Velocity Skierniewice Sp. z o.o.

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 15, 2023
• Study Start: June 20, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (31); HU (2); PL (3); AU (2)