A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing
NCT ID: NCT05857930
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
296 participants
INTERVENTIONAL
2023-06-20
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OM-85
Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.
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
Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
72 Months
ALL
No
Sponsors
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OM Pharma SA
INDUSTRY
Responsible Party
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Locations
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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
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
Monroe Carell Jr. Children's Hospital
Nashville, Tennessee, United States
Helios Clinical Research - Houston
Houston, Texas, United States
La Providence Pediatrics Clinic
Houston, Texas, United States
Prime Clinical Research Inc
Mansfield, Texas, United States
STAAMP Research
San Antonio, Texas, United States
The University of Texas Health Science Center at Tyler - Pulmonology
Tyler, Texas, United States
University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine
Madison, Wisconsin, United States
University Hospital Geelong - Barwon Health
Geelong, Victoria, Australia
The Royal Childrens Hospital
Melbourne, Victoria, Australia
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary
Aranyklinika Kft.
Szeged, Csongrád megye, Hungary
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o.
Tarnów, Lesser Poland Voivodeship, Poland
NZOZ E-Vita
Bialystok, Podlaskie Voivodeship, Poland
Velocity Skierniewice Sp. z o.o.
Skierniewice, Łódź Voivodeship, Poland
Countries
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Other Identifiers
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2024-511083-90-00
Identifier Type: CTIS
Identifier Source: secondary_id
BV-2020/09
Identifier Type: -
Identifier Source: org_study_id
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