Active not recruitingPHASE4INTERVENTIONAL

OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

This important study is investigating a new medicine, OM-85, to see if it can help young children between 6 months and 5 years old. These are children who often experience chest infections and wheezing. Many parents worry when their child is frequently unwell, and this study aims to find a way to reduce these illnesses. We will compare OM-85 to a dummy treatment (placebo) to understand if it truly works and if it's safe to use. The study will look at how many infections children get and if there are any side effects. Your child's well-being is our top priority, and all steps are taken to ensure their safety throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

OM Pharma SA

Enrolment target

525

Start

12 Dec 2022

Estimated completion

16 Sep 2026

Respiratory Tract Infections Wheezing Lower Respiratory Illness

What is this study about?

Many young children get frequent chest infections and wheezing, which can be worrying for parents and disruptive for families. This study, called ‘OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness’, is designed to explore if a medication called OM-85 can help reduce the number of these common illnesses in children aged 6 months to 5 years.

The main goal is to find out if OM-85 is both effective and safe. We will compare it to a 'placebo', which is a dummy treatment that looks just like OM-85 but contains no active medicine. This comparison helps us understand if any improvements are genuinely due to OM-85 or if they might have happened anyway. By the end of the study, we hope to have a clearer picture of whether OM-85 could be a helpful option for children who suffer from repeated chest infections.

This kind of research is very important because it helps doctors and parents make better decisions about treatments. Finding ways to reduce these infections could mean fewer trips to the doctor, less discomfort for children, and an improved quality of life for the whole family.

Key takeaways

This study aims to reduce frequent chest infections and wheezing in young children.
It tests a medicine called OM-85 against a dummy treatment (placebo).
Children aged 6 months to 5 years, with a history of recurrent infections, can take part.
Participation involves 12 months of treatment and 6 months of follow-up.
All care is taken to ensure your child's safety and well-being.
You can withdraw your child from the study at any time.

Who may be eligible?

This study is looking for young children between 6 months and 5 years old. For children aged 1 year or older, they would need to have had at least four chest infections (respiratory tract infections) in the last year, with at least two of these involving wheezing, and at least one leading to a hospital visit or doctor's appointment.

If your child is under 1 year old, they would need to have had at least two chest infections in the last six months, with at least one involving wheezing, and at least one leading to a hospital visit or doctor's appointment. Parents or legal guardians must be willing to provide written permission for their child to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 6 months and 5 years old?
If your child is 1 year or older, have they had at least 4 chest infections in the last year, with 2 or more involving wheezing (and one causing a doctor/hospital visit)?
If your child is under 1 year, have they had at least 2 chest infections in the last 6 months, with 1 or more involving wheezing (and one causing a doctor/hospital visit)?
Are there any major heart, lung, or immune system conditions your child has?
Has your child recently taken specific medications like steroids, immunosuppressants, or other similar treatments?
Are you able and willing to give written permission for your child to join the study?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they would be involved for about 18 months, plus up to 20 days for initial checks. First, there's a short screening period to make sure your child is suitable. Then, for 12 months, your child will receive either OM-85 or a placebo. This will be given in one of three ways, decided by chance: OM-85 for the whole 12 months, OM-85 for 3 months followed by a placebo for 9 months, or a placebo for the entire 12 months. Everyone involved, including the study team and your family, won't know which treatment your child is receiving – this is to make sure the results are as fair as possible. After the 12-month treatment period, there will be an additional 6 months where we keep an eye on your child's health. Throughout the study, there will be regular check-ups to monitor your child's health and any infections they might get.

Potential risks and benefits

Taking part in a clinical trial offers the chance for your child to receive a new treatment that might help reduce their recurrent chest infections and wheezing. However, there's no guarantee it will work, and your child might receive a placebo. Like all medicines, OM-85 could have side effects, and these will be carefully monitored. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (42)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ludwig Maximilians Universität München
Verified postcode
München, Germany
Clinical Research & Healthcare GmbH
Verified postcode
Schönau am Königssee, Germany
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany
St. Josef-Hospital
Verified postcode
Bochum, Germany
University Hospital Cologne AöR
Verified postcode
Cologne, Germany
Ev. Krankenhaus Düsseldorf
Verified postcode
Düsseldorf, Germany
Praxis Köllges
Verified postcode
Mönchengladbach, Germany
Marien-Hospital Wesel gGmbH
Verified postcode
Wesel, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Verified postcode
Lübeck, Germany
Aranyklinika Kft
Verified postcode
Szeged, Hungary
Dr. Kenessey Albert Korhaz-Rendelointezet
Verified postcode
Balassagyarmat, Hungary
Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika
Verified postcode
Budapest, Hungary

Common questions

What is OM-85?

OM-85 is the name of the medicine being tested in this study to see if it can help children with frequent chest infections.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It helps us compare and see if the real medicine is effective.

Will I know if my child is getting OM-85 or the placebo?

No, neither you nor the study team will know which treatment your child is receiving until the end of the study. This ensures the results are unbiased.

How long will my child be in the study?

The total time commitment for your child would be about 18 months, plus a short initial screening period.

What are 'respiratory tract infections'?

These are common infections that affect the nose, throat, airways, and lungs, often leading to symptoms like coughing, sneezing, and wheezing.