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Study on the Effectiveness and Safety of OM-85 for Children Aged 6 Months to 5 Years with Recurrent Wheezing

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called OM-85 in children who experience recurrent wheezing. Recurrent wheezing is a condition where children have repeated episodes of wheezing, which is a high-pitched whistling sound made while breathing. The study will compare the effects of OM-85 with a placebo, which is a substance with no active medication, to see if OM-85 can help reduce the frequency of these wheezing episodes.

The treatment being tested, OM-85, is made from lyophilized bacterial lysates, which are small parts of bacteria that have been dried and processed. These bacterial lysates come from several types of bacteria, including Haemophilus influenzae and Streptococcus pneumoniae. The study aims to determine if taking OM-85 daily can decrease the number of wheezing episodes in children aged 6 months to 5 years over a period of six months.

Participants in the study will be randomly assigned to receive either OM-85 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The main goal is to see if OM-85 can effectively reduce the rate of wheezing episodes compared to the placebo during the treatment period. Safety and any side effects will also be monitored throughout the study.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the child must be between 6 months and 5 years old and have a history of recurrent wheezing.
The child must have an up-to-date vaccination status according to local requirements.
Written informed consent must be provided by the parents or legal guardians before any study-specific procedures are performed.
Step 2
Treatment period
The treatment period lasts for 6 months.
During this time, the child will receive either the medication OM-85 or a placebo. The medication is administered orally in the form of hard capsules.
The dosage of OM-85 is 3.5 mg per capsule, taken daily.
Step 3
Monitoring and assessment
Throughout the 6-month treatment period, the child's health will be monitored to assess the rate of wheezing episodes.
The study will track the number of severe wheezing episodes and any episodes requiring treatment with oral corticosteroids (OCS).
The number of days with wheezing or asthma-like symptoms will also be recorded.
Safety assessments will include monitoring for any adverse events, serious adverse events, and changes in vital signs and physical examination results.
Step 4
Completion of the study
At the end of the 6-month treatment period, the study will conclude.
The final assessments will be conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

5 criteria

Children of any gender, aged between 6 months and 5 years.
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Children with **recurrent wheezing**. This means they have had repeated episodes of wheezing, which is a whistling sound when breathing. The specific requirements are:
- For children who have not used or only occasionally used certain medications like **ICS** (inhaled corticosteroids) or **LTRA** (leukotriene receptor antagonists): They must have had at least 2 wheezing episodes, including at least 1 severe episode treated with **OCS** (oral corticosteroids) or that required a visit to the emergency department or hospitalization. Alternatively, they must have had at least 3 wheezing episodes, with one leading to an unscheduled doctor visit, as reported by parents or guardians, in the past 12 months.
- For children who use **ICS** or **LTRA** daily: They must have had at least 1 severe wheezing episode treated with **OCS** or that required a visit to the emergency department or hospitalization. Alternatively, they must have had at least 2 wheezing episodes, with one leading to an unscheduled doctor visit, as reported by parents or guardians, in the past 12 months, while on their daily medication.
- Children must be up-to-date with their vaccinations according to the requirements for school or daycare entry in their state or country.
- Parents or guardians must provide written informed consent before any study-specific procedures are performed, including screening procedures.

Who cannot join the trial?

7 criteria

Children who do not have recurrent wheezing. Recurrent wheezing means having episodes of wheezing, which is a whistling sound when breathing, happening more than once.
Children who are not between 6 months to 5 years old.
Children who have other medical conditions that might interfere with the study.
Children who are currently taking medications that could affect the study results.
Children who have participated in another clinical trial recently.
Children who have a known allergy to the study medication or its ingredients.
Children whose parents or guardians do not agree to follow the study procedures.

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Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Lodz, Poland

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Investigated drugs

OM-85 is a medication being studied to see if it can help reduce the frequency of wheezing episodes in young children. It is given daily to children aged 6 months to 5 years who have had recurrent wheezing. The goal is to determine if this treatment is effective and safe for managing wheezing in this age group.

What is already known about the treatment

OM-85 – OM-85 is administered orally, typically in the form of capsules or tablets, and is currently being studied in clinical trials for its potential benefits in treating recurrent wheezing in young children. It is not yet widely established in medical practice, as research is ongoing to determine its efficacy and safety. The main therapeutic indication for OM-85 is to reduce the frequency of wheezing episodes in children aged 6 months to 5 years. At the molecular level, OM-85 is believed to work by modulating the immune system, enhancing the body's defense mechanisms against respiratory infections. It is classified pharmacologically as an immunomodulator.

Investigated diseases

Recurrent Wheezing – Recurrent wheezing is a condition characterized by repeated episodes of wheezing, which is a high-pitched whistling sound made while breathing. It often occurs in young children and can be triggered by various factors such as respiratory infections, allergens, or changes in weather. The condition involves inflammation and narrowing of the airways, leading to difficulty in breathing. Over time, these episodes can become more frequent and may be associated with other symptoms like coughing and shortness of breath. The progression of recurrent wheezing can vary, with some children outgrowing the condition while others may develop asthma. Monitoring and managing triggers are essential to reduce the frequency and severity of wheezing episodes.