Home › Trials › NCT05857930

Assessing OM-85 for treating recurrent wheezing in young children

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

Phase 2 Interventional OM Pharma SA · NCT05857930

This study is testing if a daily treatment called OM-85 can help young children with recurrent wheezing breathe better and have fewer wheezing episodes.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment288 (estimated)
Ages6 Months to 72 Months
SexAll
SponsorOM Pharma SA Industry-sponsored
Locations39 sites (Phoenix, Arizona and 38 other locations)
Trial IDNCT05857930 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the efficacy and safety of daily OM-85 treatment compared to a placebo in children aged 6 months to 5 years who experience recurrent wheezing. The study is designed as a randomized, double-blind, placebo-controlled, multicenter trial lasting 12 months, which includes a 6-month treatment period followed by a 6-month observational period. Participants will be monitored for the frequency of wheezing episodes and overall respiratory health while receiving standard care. The goal is to determine if OM-85 can effectively reduce wheezing episodes in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to 5 years with a history of recurrent wheezing episodes.

Not a fit: Patients who do not have recurrent wheezing or are not within the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of wheezing episodes in young children, improving their respiratory health and quality of life.

How similar studies have performed: Previous studies have shown promise in using immunomodulatory treatments for respiratory conditions, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
* 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 (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 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.
* 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 this trial is running

Phoenix, Arizona and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Recurrent WheezingWheezing Lower Respiratory IllnessInnate immune responseType 1 immune responseType 2 immune responseBacterial lysateImmunomodulationEAGLE
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.