OM-85 for Recurrent Wheezing

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: OM Pharma SA

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Chronic respiratory diseases, Autoimmune, HIV, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial will test if daily OM-85 can reduce wheezing episodes in young children who often experience them. The study will focus on children aged 6 months to 5 years. OM-85 aims to help the immune system fight off infections that cause wheezing. OM-85 has been shown to reduce the risk of recurrent respiratory tract infections and wheezing attacks in children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain medications like systemic steroids or immunosuppressants recently. It's best to discuss your specific medications with the trial team.

How is the drug OM-85 unique for treating recurrent wheezing?

OM-85 is unique because it is an oral immunotherapy made from bacterial extracts that boosts the body's immune response to reduce respiratory infections, unlike other treatments that may focus on directly relieving wheezing symptoms. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for children aged 6 months to 5 years with recurrent wheezing who are not currently very sick, have up-to-date vaccinations, and haven't used certain immune treatments recently. Kids born prematurely or with significant health issues like low/high weight, recent major surgery, chronic diseases other than wheezing, or immune deficiencies can't join.

Inclusion Criteria

My child is between 6 months and 5 years old.

My breathing problems have been gone for at least a week.

My child has recurrent wheezing and hasn't used ICS/LTRA much or uses it daily.

Exclusion Criteria

I have not had major surgery in the last 3 months.

I have or had another type of cancer.

I haven't had any systemic or steroid treatments in the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Treatment

Participants receive daily OM-85 or placebo treatment for 6 months

6 months

Observational

Participants are observed without treatment to assess long-term effects and safety

6 months

Follow-up

Participants are monitored for safety and effectiveness after the observational period

4 weeks

Treatment Details

Interventions

• OM-85 (Immunomodulator)
• Placebo (Other)

Trial Overview The study tests the effectiveness and safety of OM-85, a daily treatment for young kids with recurrent wheezing. It's compared against a placebo (a substance with no active drug). Children will be randomly assigned to either receive OM-85 or the placebo.

Participant Groups

Group I: OM-85 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

OM-85 is already approved in Switzerland for the following indications:

Approved in Switzerland as Broncho-Vaxom for:

• Prevention of recurrent respiratory infections
• Chronic bronchitis
• COPD

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Prime Clinical Research Inc Mansfield, TX

Velocity Clinical Research - Lafayette Lafayette, LA

UCSF Benioff Children's Hospital Oakland Primary Care Clinic Oakland, CA

Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics Aurora, CO

More Trial Locations

Who Is Running the Clinical Trial?

OM Pharma SA

Lead Sponsor

Trials

7

Recruited

1,700+

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Findings from Research

In a study of 116 children aged 6 months to 19 years, those taking Broncho-Vaxom/Imocur (OM-85 BV) experienced significantly fewer infections (39.5% remained infection-free) compared to those on placebo (16.5%), indicating its efficacy as an immunotherapy for recurrent respiratory and ENT infections.

The treatment also reduced the need for antibiotics, with 44% of children on OM-85 BV not requiring them, compared to 23.5% on placebo, and it was well-tolerated with no reported adverse effects, confirming its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy with an oral bacterial extract (OM-85 BV) for upper respiratory infections. Paupe, J.[2018]

Broncho-Vaxom® (OM-85 BV) significantly enhances ciliary beat frequency and nitric oxide production in human sinonasal epithelial cells, indicating its potential to improve respiratory mucosal immunity.

The effects of OM-85 BV are mediated through the activation of bitter taste receptors (T2R), suggesting a novel mechanism of action that contributes to its efficacy in preventing respiratory infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broncho-Vaxom® (OM-85 BV) soluble components stimulate sinonasal innate immunity. Triantafillou, V., Workman, AD., Patel, NN., et al.[2020]

In a study of 62 children with asthma and recurrent respiratory infections, treatment with OM-85 BV significantly reduced the frequency of respiratory infections and increased serum levels of hBD-1, IgA, and IgG after 6 and 12 months.

The treatment was associated with mild adverse reactions in a few cases, indicating that OM-85 BV is both effective and generally safe for improving respiratory health in children with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of OM-85 BV on hBD-1 and immunoglobulin in children with asthma and recurrent respiratory tract infection]. Liao, JY., Zhang, T.[2014]

OM-85 BV has been shown to effectively reduce the number of acute exacerbations of ENT and respiratory tract infections across all age groups, as evidenced by multiple controlled clinical trials.

The use of OM-85 BV not only increased the number of patients remaining free from infections but also led to a decrease in antibiotic consumption, highlighting its role in promoting oral immunostimulation and protecting against recurrent airway infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with OM-85 BV in upper and lower respiratory tract infections. Derenne, JP., Delclaux, B.[2018]

Broncho-Vaxom (OM-85 BV) enhances the immune response in the respiratory tract by increasing the transcription and secretion of cytokines IL-6 and IL-8 in human lung fibroblasts, which may help in fighting bacterial infections.

The study indicates that the immunological benefits of OM-85 BV, such as increased serum IgG and decreased IgE levels, could be linked to its ability to modulate cytokine expression through the C-Fos/serum responsive element pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of interleukin 6 and interleukin 8 expression by Broncho-Vaxom (OM-85 BV) via C-Fos/serum responsive element. Keul, R., Roth, M., Papakonstantinou, E., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Immunotherapy with an oral bacterial extract (OM-85 BV) for upper respiratory infections. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Broncho-Vaxom® (OM-85 BV) soluble components stimulate sinonasal innate immunity. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[Influence of OM-85 BV on hBD-1 and immunoglobulin in children with asthma and recurrent respiratory tract infection]. [2014]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical experience with OM-85 BV in upper and lower respiratory tract infections. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Induction of interleukin 6 and interleukin 8 expression by Broncho-Vaxom (OM-85 BV) via C-Fos/serum responsive element. [2019]