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Recurrent WheezingPhase 2NCT05857930

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

A Phase 2 study testing OM-85 in people with Recurrent Wheezing and Wheezing Lower Respiratory Illness, run by OM Pharma SA at 38 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 6 to 72 months
What is being tested?
OM-85
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
296 participants
Where
38 sitesin 4 countries
Study dates
20 Jun 2023to 15 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 72 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

38 sites in 4 countries.

38 sites in 4 countries

United States31 sites

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

    Aurora, Colorado, 80045-7106

  • Kern Research Inc.

    Bakersfield, California, 93301

  • Velocity Clinical Research - Binghamton

    Binghamton, New York, 13905

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • UNC Hospitals, The Univ of NC at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • BioMD Clinical Research

    Coral Gables, Florida, 33134

  • American Research Institute, INC

    Cutler Bay, Florida, 33157

  • Hoag Health Center Foothill Ranch

    Foothill Ranch, California, 92610

  • Northwell Health/Division of Allergy & Immunology

    Great Neck, New York, 11021

  • Helios Clinical Research - Houston

    Houston, Texas, 77008

  • La Providence Pediatrics Clinic

    Houston, Texas, 77071

  • Riley Children's Health - Pediatrics

    Indianapolis, Indiana, 46202

  • Velocity Clinical Research - Lafayette

    Lafayette, Louisiana, 70508

  • Arkansas Children's Hospital Research Institute

    Little Rock, Arkansas, 72202

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

    Madison, Wisconsin, 53792-9988

  • Prime Clinical Research Inc

    Mansfield, Texas, 76063

  • C & R Research Services USA. Inc

    Miami, Florida, 33183

  • Monroe Carell Jr. Children's Hospital

    Nashville, Tennessee, 37821

  • UCSF Benioff Children's Hospital Oakland Primary Care Clinic

    Oakland, California, 94618

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Allergy & Asthma Specialists PSC

    Owensboro, Kentucky, 42301

  • Arizona Medical Clinic

    Phoenix, Arizona, 85015

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • STAAMP Research

    San Antonio, Texas, 78229

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

    San Diego, California, 92123

  • Rady Children's Hospital

    San Diego, California, 92123

  • The University of Arizona Medical Center - University Campus

    Tucson, Arizona, 85724

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

  • The University of Texas Health Science Center at Tyler - Pulmonology

    Tyler, Texas, 75708-3154

Other trials in United States

Poland3 sites

  • NZOZ E-Vita

    Bialystok, Podlaskie Voivodeship, 15-879

  • Velocity Skierniewice Sp. z o.o.

    Skierniewice, Łódź Voivodeship, 96-100

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

    Tarnów, Lesser Poland Voivodeship, 33-100

Other trials in Poland

Australia2 sites

  • University Hospital Geelong - Barwon Health

    Geelong, Victoria, 3220

  • The Royal Childrens Hospital

    Melbourne, Victoria, 3052

Other trials in Australia

Hungary2 sites

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz

    Miskolc, Borsod-Abauj Zemplen county, 3526

  • Aranyklinika Kft.

    Szeged, Csongrád megye, 6720

Other trials in Hungary

About this study

Official title: 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

Read the 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.

Being tested
OM-85, Placebo
Keywords
Innate immune response, Type 1 immune response, Type 2 immune response, Bacterial lysate, Immunomodulation, EAGLE
Medical subject headings
Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OM-85Drug

    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.

  • PlaceboDrug

    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.

Study groups in NCT05857930
Study groupRoleWhat they receive
OM-85ExperimentalPatients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.
Receives: Drug: OM-85
PlaceboPlacebo comparatorPatients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 Months

Secondary outcomes (18)

  1. 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.

    Measured: 6 Months

  2. Rate 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.

    Measured: 6 Months

  3. 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.

    Measured: 6 Months

  4. 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.

    Measured: From Month 6 up to Month 12

  5. Rate 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.

    Measured: From Month 6 up to Month 12

  6. 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.

    Measured: 12 Months

  7. 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.

    Measured: 12 Months

  8. 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.

    Measured: 12 Months

  9. 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.

    Measured: 12 Months

  10. 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.

    Measured: 12 Months

  11. 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, the 6-month observational period and the whole study period.

    Measured: 12 Months

  12. 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.

    Measured: 12 Months

  13. 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).

    Measured: 12 Months

  14. 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.

    Measured: 12 Months

  15. 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.

    Measured: 12 Months

  16. 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.

    Measured: 12 Months

  17. 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, during the 6-month observational period and during the whole study period.

    Measured: 12 Months

  18. 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.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2023
  2. Study start20 Jun 2023
  3. Primary completion15 Sep 2026
  4. Study completion15 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05857930
Sponsor's protocol ID
BV-2020/09
Other IDs
2024-511083-90-00
Status last verified
Oct 2026
First submitted
4 May 2023
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OM-85 in people with Recurrent Wheezing and Wheezing Lower Respiratory Illness, run by OM Pharma SA at 38 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Poland, Australia, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Wheezing/Asthma like episodes (WEs) (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05857930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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