OM-85 for Recurrent Wheezing

Recruiting at 33 trial locations

Overseen By Lorenz Lehr

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: OM Pharma SA

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Chronic respiratory diseases, Autoimmune, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of OM-85, an immunotherapy, for young children who frequently wheeze. Researchers aim to determine if OM-85 reduces wheezing episodes compared to a placebo, which contains no active medicine. Children with frequent wheezing episodes, particularly severe ones requiring emergency care, may qualify. Participants will take either the treatment or placebo for six months, followed by six months of observation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that OM-85 is likely to be safe for children with recurrent wheezing?

Research has shown that OM-85, a medicine that boosts the immune system, is generally safe for children who often experience wheezing. One study found that taking OM-85 for three months reduced the risk of respiratory infections and was well-tolerated by children. Another study demonstrated that OM-85 safely reduced wheezing caused by viral infections in preschool children. Additionally, in a study with 75 children who had frequent wheezing, those taking OM-85 did not experience major safety issues. Overall, the evidence suggests that OM-85 is safe for children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for recurrent wheezing, which often include inhaled corticosteroids and bronchodilators, OM-85 offers a unique approach by targeting the immune system. OM-85 is derived from bacterial extracts and is thought to work by enhancing the body's immune response, potentially reducing the frequency and severity of wheezing episodes. Researchers are excited about OM-85 because it represents a novel mechanism of action that could provide benefits beyond symptom management, possibly preventing wheezing from occurring in the first place. This could be a game-changer for individuals who experience recurrent wheezing and are looking for more proactive treatment options.

What evidence suggests that OM-85 might be an effective treatment for recurrent wheezing?

Research has shown that OM-85, which participants in this trial may receive, can help reduce respiratory infections in children. One study found it could prevent about 1.26 infections over six months. Another study demonstrated that OM-85 significantly lowered the number of wheezing attacks, common in children with breathing problems. This treatment appears to strengthen the immune system, aiding the body in fighting off infections that can cause wheezing. Overall, OM-85 has shown promise in reducing both infections and wheezing episodes in children. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• OM-85
• Placebo

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.

How Is the Trial Designed?

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 European Union, Switzerland for the following indications:

Approved in European Union as Broncho-Vaxom for:

• Prevention of recurrent respiratory infections
• Chronic bronchitis
• COPD

Approved in Switzerland as Broncho-Vaxom for:

• Prevention of recurrent respiratory infections
• Chronic bronchitis
• COPD

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11296687/

A critical analysis of the effect of OM-85 for the prevention of ... OM-85 BV could reduce the incidence of RTIs by 0.21 times per month; that is, ~1.26 fewer RTIs every half-year.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00733226

NCT00733226 | Effect of OM-85 BV on Wheezing Related ... The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 ...

3. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-022-02264-9

OM-85 BV in pediatric recurrent respiratory tract infections Using OM-85 BV prevention, 1.52 infections were prevented in 6 months saving 67.83 Euro on the costs of care for the recurrently infected child.

4. jacionline.org jacionline.org/article/S0091-6749%2810%2901189-9/fulltext

The immunostimulant OM-85 BV prevents wheezing ... We demonstrated in our study that treatment with OM-85 BV significantly reduced the incidence of acute wheezing attacks. The effects seem to be secondary to a ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/21645515.2022.2106720

Full article: Expert consensus on the role of OM-85 in ... Efficacy and safety of OM-85 in paediatric recurrent respiratory tract infections which could have a possible protective effect on COVID-19 pandemic: a meta ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369215523222

Safety and Efficacy of Two Courses of OM-85 BV in the ... The study included 75 children with recurrent wheezing who were 1 to 6 years old. Participants were randomly assigned to groups given either OM-85 BV or a ...

7. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-019-2040-y

A randomized, placebo-controlled, double-blinded, single ... The use of OM-85 for 3 months in 3 series of 10 consecutive days each time reduces the risk of recurrent RTIs in children, with a favourable safety profile.