What side effects are associated with this type of intervention?

Common treatments for asthma include inhaled corticosteroids, bronchodilators (such as LABAs and SABAs), and immunomodulators. Inhaled corticosteroids can cause side effects like oral thrush, hoarseness, and, in rare cases, systemic effects such as adrenal suppression. Bronchodilators may lead to side effects such as tremors, palpitations, and headaches. Immunomodulators, like OM-85, which aim to reduce respiratory infections and inflammation, are generally well-tolerated but can occasionally cause gastrointestinal disturbances, skin reactions, and mild respiratory symptoms. It is important to discuss potential side effects with a healthcare provider to tailor the treatment to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for asthma, including immunomodulators that target specific pathways in the immune system. For example, mepolizumab, an interleukin-5 (IL-5) antagonist, has been approved for severe eosinophilic asthma. It works by reducing the levels of eosinophils, a type of white blood cell involved in inflammation. Other similar treatments include omalizumab, an anti-IgE antibody, which is used for allergic asthma by blocking IgE, a key antibody in allergic reactions. These treatments aim to reduce inflammation and prevent asthma exacerbations, similar to the immunomodulatory approach of OM-85, which stimulates the immune system to reduce respiratory infections and inflammation.

What other types of research exist?

Promising novel alternatives to OM-85 for asthma patients include: 1) Omalizumab, an anti-IgE monoclonal antibody, which has shown effectiveness in reducing exacerbations and hospitalizations in severe asthma. 2) Dupilumab, an anti-IL-4 receptor antibody, which inhibits IL-4 and IL-13 signaling and has shown efficacy in asthma management. 3) Ligelizumab, another anti-IgE monoclonal antibody, which has higher potency compared to omalizumab and is being evaluated for its efficacy in asthma.

← Back to Search

Immunomodulator

OM-85 for Recurrent Wheezing

Phase 2

Recruiting

Research Sponsored by OM Pharma SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children of either gender, aged between 6 and 72 months (5 years inclusive)

Be younger than 18 years old

Must not have

Any known neoplasia or malignancy

Treatment with systemic (intravenous or intramuscular) or OCS within 4 weeks before study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from month 6 up to month 12

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of OM-85 aren't listed here, common ones in trials may include reactions at the site of administration, gastrointestinal symptoms like nausea or diarrhea, headaches, rash or potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 6 months and 5 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or had another type of cancer.

Select...

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

Select...

I do not have chronic respiratory diseases like tuberculosis or cystic fibrosis.

Select...

I have significant lung, heart, liver, or kidney problems.

Select...

I was born before reaching 34 weeks of pregnancy.

Select...

My wheezing is caused by acid reflux.

Select...

I have known changes in my airways.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from month 6 up to month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from month 6 up to month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and from month 6 up to month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Wheezing/Asthma like episodes (WEs)

Secondary study objectives

Duration in days of WEs and severe WEs

Duration of routine asthma treatment

Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OM-85Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments generally fall into several categories: bronchodilators, corticosteroids, leukotriene modifiers, and immunomodulators. Bronchodilators, such as beta-agonists, work by relaxing the muscles around the airways, making it easier to breathe. Corticosteroids reduce inflammation in the airways, preventing asthma attacks. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Immunomodulators, like OM-85, stimulate the immune system to reduce respiratory infections and inflammation, which can decrease the frequency and severity of asthma exacerbations. These mechanisms are crucial for asthma patients as they help manage symptoms, prevent attacks, and improve overall lung function, thereby enhancing quality of life.

Clinical and Immunological Benefits of OM-85 Bacterial Lysate in Patients with Allergic Rhinitis, Asthma, and COPD and Recurrent Respiratory Infections.Omalizumab management beyond clinical trials: the added value of a network model.Omalizumab for asthma in adults and children.