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A clinical study investigating OM-85 efficacy and safety in children suffering from Recurrent Wheezing
EU CTIS ID: 2024-511083-90-00
What this study is testing
To assess the efficacy of OM-85 in reducing the rate of WEs vs. placebo during the 6month Treatment period in children aged 6 months to 5 years with previous recurrent WEs
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children of either gender, aged between 6 and 72 months (5 years inclusive).
- Children with recurrent wheezing: a. For ICS/LTRA naïve patients or intermittent users: ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including one that triggered an unscheduled physician visit, as reported by parents or LAR of subject, in the 12 months prior to enrollment. b. For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS or having triggered an ED visit/hospitalization) OR ≥2 WEs including one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy. Note: While WE counted for enrollment are based on parent reporting, the PI must ensure that they fulfill the WE definition of the protocol.
- Up-to-date vaccination status as per applicable State Or Country Vaccination Requirements for school/daycare entry.
- Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
You likely can't join if
- Known anatomic alterations of the respiratory tract.
- Treatment with the following medications: a. Systemic (intravenous or intramuscular) or oral corticosteroids or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment.
- Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
- Known allergy or previous intolerance to investigational drug.
- Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
- Other household members have previously been randomized in this clinical study.
See the full eligibility criteria
Who can join
- Children of either gender, aged between 6 and 72 months (5 years inclusive).
- Children with recurrent wheezing: a. For ICS/LTRA naïve patients or intermittent users: ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including one that triggered an unscheduled physician visit, as reported by parents or LAR of subject, in the 12 months prior to enrollment. b. For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS or having triggered an ED visit/hospitalization) OR ≥2 WEs including one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy. Note: While WE counted for enrollment are based on parent reporting, the PI must ensure that they fulfill the WE definition of the protocol.
- Up-to-date vaccination status as per applicable State Or Country Vaccination Requirements for school/daycare entry.
- Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
What rules you out
- Known anatomic alterations of the respiratory tract.
- Treatment with the following medications: a. Systemic (intravenous or intramuscular) or oral corticosteroids or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment.
- Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
- Known allergy or previous intolerance to investigational drug.
- Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
- Other household members have previously been randomized in this clinical study.
- Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
- Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s).
- Wheezing documented to be caused by gastroesophageal reflux.
- Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).
- Any known autoimmune disease.
- Known HIV infection or any known type of congenital or iatrogenic immune deficiency (including IgA deficiency).
- Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities.
- Children born prematurely, i.e., before 34 weeks of gestational age.
- Children with an abnormally low or high weight for their age and height, if in the opinion of the Investigator, this would not allow safe completion of the clinical study.
- Any known neoplasia or malignancy.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.