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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Recurrent Wheezing, Wheezing Lower Respiratory Illness

In brief

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

Key facts

Study ID: NCT05857930
Run by: OM Pharma SA
People needed: 296
Starts: 2023-06-20
Expected to finish: 2026-09-30
Last updated by the study team: 2026-02-23

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

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.
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.

Where it is running

Aranyklinika Kft. — Szeged, Csongrád megye, Hungary
Arizona Medical Clinic — Phoenix, Arizona, United States
Phoenix Children's Hospital — Phoenix, Arizona, United States
The University of Arizona Medical Center - University Campus — Tucson, Arizona, United States
Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
Kern Research Inc. — Bakersfield, California, United States
Hoag Health Center Foothill Ranch — Foothill Ranch, California, United States
UCSF Benioff Children's Hospital Oakland Primary Care Clinic — Oakland, California, United States
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology — San Diego, California, United States
Rady Children's Hospital — San Diego, California, United States
Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics — Aurora, Colorado, United States
BioMD Clinical Research — Coral Gables, Florida, United States
American Research Institute, INC — Cutler Bay, Florida, United States
C & R Research Services USA. Inc — Miami, Florida, United States
Rush University Medical Center — Chicago, Illinois, United States
Riley Children's Health - Pediatrics — Indianapolis, Indiana, United States
Allergy & Asthma Specialists PSC — Owensboro, Kentucky, United States
Velocity Clinical Research - Lafayette — Lafayette, Louisiana, United States
Boston Children's Hospital — Boston, Massachusetts, United States
Velocity Clinical Research - Binghamton — Binghamton, New York, United States
Northwell Health/Division of Allergy & Immunology — Great Neck, New York, United States
UNC Hospitals, The Univ of NC at Chapel Hill — Chapel Hill, North Carolina, United States
Cincinnati Children'S Hospital Medical Center — Cincinnati, Ohio, United States
Allergy, Asthma and Clinical Research Center — Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, PC — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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