A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

• Status: Not yet recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OM Pharma SA
• Collaborator: Parexel

Criteria

Inclusion Criteria:

Subjects who meet all the following criteria will be included in the study:

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

• Children with recurrent wheezing:

• For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including at least 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.

• For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR ≥2 WEs including at least one that triggered an unscheduled physician visit, in the 12 months prior to enrollment, while being on their daily controller therapy.

• Up-to-date vaccination status against respiratory pathogens as per Centers for Disease Control and Prevention (CDC) recommendations

• 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.

Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week.

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 human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A 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.

• Malnutrition as per World Health Organization (WHO) definition, meaning children having a weight lower than the 5th percentile and higher than the 85th percentile for their age range according to WHO weight for age charts from birth to 5 years. Children of 6 months of age at enrollment will be excluded from the study if they have a weight lower than 6 kg and 6.6 kg, for girls and boys respectively.

• Any known neoplasia or malignancy.

• Treatment with the following medications:

• Systemic (intravenous or intramuscular) or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment.

• 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.

• 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).

Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.