Efficacy and Safety of OM-85 in Pediatric Patients with Recurrent Wheezing: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
- Trial ID
- 2024-511083-90-00
- Protocol
- BV-2020/09
- Sponsor
- OM Pharma SA
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **efficacy** of OM-85 in reducing the rate of wheezing episodes (WEs) compared to placebo during a 6-month treatment period in children aged 6 months to 5 years with a history of recurrent wheezing. This is clinically relevant as recurrent wheezing in young children can lead to significant respiratory morbidity and impact quality of life, and effective management strategies are essential for improving patient outcomes.
Secondary objectives include:
- Assessing the efficacy of OM-85 in reducing the rate of severe WEs compared to placebo during the 6-month treatment period.
- Evaluating the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs compared to placebo during the 6-month treatment period.
- Determining the efficacy of OM-85 in decreasing the cumulative number of days with WEs compared to placebo during the 6-month treatment period.
- Assessing the safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent WEs during the 6-month treatment period and the subsequent 6-month observational period.
Participants
The clinical trial involves a total of **203 participants** who are children aged between **6 months and 5 years**. The study population includes both **male and female** subjects who have experienced **recurrent wheezing**. Participants were selected based on specific criteria, including a history of wheezing episodes (WEs) as reported by parents or legal authorized representatives (LAR) within the 12 months prior to enrollment. The trial includes children who are either naïve to or intermittent users of inhaled corticosteroids (ICS) or leukotriene receptor antagonists (LTRA), as well as those on daily controller therapy. All participants have an up-to-date vaccination status according to applicable state or country requirements for school or daycare entry. The trial population is considered vulnerable due to the young age of the participants. The selection process ensured that informed consent was obtained from parents or LARs before any study-specific procedures were conducted.
Plans and Procedures
The clinical trial is designed as a **randomized, placebo-controlled, double-blind, multicenter, Phase 2 study** to evaluate the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with **recurrent wheezing**. The primary objective is to assess the efficacy of OM-85 in reducing the rate of wheezing episodes (WEs) during a 6-month treatment period. The trial is expected to commence recruitment on August 1, 2024, and conclude by February 28, 2026.
Participants will be involved in the study for a maximum of 180 days, during which they will receive either the active treatment or placebo. The study will include several key visits: an initial screening visit to confirm eligibility based on inclusion criteria such as age, history of recurrent wheezing, and vaccination status; regular follow-up visits to monitor the rate of WEs, safety, and any adverse events; and an end-of-study visit to assess the overall outcomes and collect final data. The inclusion criteria require children to have experienced a specified number of WEs in the 12 months prior to enrollment, with variations based on their current treatment regimen.
Participants may be withdrawn from the study early if they experience significant adverse events, fail to comply with the study protocol, or if the investigator deems it necessary for their safety. The primary endpoint is the rate of WEs during the treatment period, while secondary endpoints include the rate of severe WEs, the number of WEs requiring oral corticosteroid treatment, and the number of days with wheezing symptoms. Safety assessments will include monitoring adverse events, serious adverse events, vital signs, and physical examinations.
Treatment
The clinical trial involves the administration of **BRONCHO-VAXOM**, a pharmaceutical product formulated as hard capsules containing **3.5 mg** of **lyophilized bacterial lysates**. The active substances include lysates from various bacteria such as **Haemophilus influenzae**, **Streptococcus (Diplococcus) pneumoniae**, **Klebsiella pneumoniae and ozaenae**, **Staphylococcus aureus**, **Streptococcus pyogenes and viridans**, and **Moraxella (Branhamella/Neisseria) catarrhalis**. The product is administered orally, with a maximum daily dose of **3.5 mg** and a total maximum dose of **630 mg** over a treatment period of **180 days**. The product is manufactured by **OMEDICAMED UNIPESSOAL LDA** and is identified by the marketing authorization number **R/0438**. The trial aims to evaluate the efficacy of this treatment in reducing the rate of wheezing episodes in children aged 6 months to 5 years with recurrent wheezing.
The study also includes a **placebo** group, which receives **BRONCHO-VAXOM Children Capsules placebo**. The placebo is designed to match the experimental medication in appearance and administration route to maintain the double-blind nature of the trial. The placebo capsules are administered orally, following the same dosing schedule as the active treatment group. This ensures that any observed effects can be attributed to the active treatment rather than psychological or other non-specific effects. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the protocol.
Efficacy
The efficacy of the clinical trial will be assessed by evaluating the primary and secondary endpoints over a 6-month treatment period. The primary endpoint is the rate of wheezing/asthma-like episodes (WEs) experienced by subjects during this period. Secondary endpoints include the rate of severe WEs, the number of WEs requiring oral corticosteroid (OCS) treatment, and the number of days with wheezing/asthma-like symptoms. These parameters will be measured and collected systematically throughout the trial to ensure accurate and reliable data. The analysis will focus on comparing the efficacy of daily OM-85 treatment against a placebo in reducing these episodes in children aged 6 months to 5 years with recurrent wheezing. Safety assessments, including adverse events (AEs), serious adverse events (SAEs), vital signs, and physical examinations, will also be conducted to ensure the well-being of participants.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Known anatomic alterations of the respiratory tract.
- 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.
- 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).
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Hungary | Not Recruiting | 01 Aug 2024 | 67 |
 Poland | Not Recruiting | 01 Aug 2024 | 59 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
BRONCHO-VAXOM, 3,5mg, kapsułki | Test | KAPSUŁKI | ORAL USE | 3.5 | 180 | PRD9719117 |
BRONCHO-VAXOM Children Capsules placebo | Placebo | N/A | — | — | — | N/A |