Clinical trial NCT05857930: A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo Given in Children Aged 6 Months to 5 Years With Recurrent Wheezing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Wheezing
Wheezing Lower Respiratory Illness
Keywords: Innate immune response
Type 1 immune response
Type 2 immune response
Bacterial lysate
Immunomodulation
EAGLE
Lead sponsor: OM Pharma SA
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 288
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This study is a 12-months phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of daily treatment with OM-85 compared to placebo, when given on top of standard of care treatment, in reducing wheezing/asthma like episodes (WEs) during the 6-month treatment period in children aged 6 months to 5 years with previous recurrent WEs.

Patients will be randomized in a 1:1 ratio to OM-85 or placebo. The study consists of screening period (Day -20 to Day -1), a treatment period of 6 months, and an observational period of 6 months without treatment. Thus, the total duration of the study for each patient will be 12 months (±10 days) + up to 20 days for screening.

Eligibility 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, 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, 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.
* Up-to-date vaccination status as per applicable State or country Vaccination Requirements for school/day-care 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.

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.
* Children with an abnormally low or high weight for their age and height, if this would not allow safe completion of the clinical study in the opinion of the investigator.
* 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 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).

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

Primary outcomes:
measure: Rate of Wheezing/Asthma like episodes (WEs)
timeFrame: 6 Months
Secondary outcomes:
measure: Rate of severe WEs
timeFrame: 6 Months
measure: Number of WE requiring oral corticosteroid (OCS) treatment during 6-month treatment period
timeFrame: 6 Months
measure: Number of days with WEs
timeFrame: 6 Months
measure: Rate of WEs and severe WEs
timeFrame: From Month 6 up to Month 12
measure: Number of WE requiring OCS treatments during 6-month observational period
timeFrame: From Month 6 up to Month 12
measure: Duration in days of WEs and severe WEs
timeFrame: 12 Months
measure: Time to treatment failure
timeFrame: 12 Months
measure: Time to first, second and third WE
timeFrame: 12 Months
measure: Number of routine asthma treatment
timeFrame: 12 Months
measure: Duration of routine asthma treatment
timeFrame: 12 Months
measure: Percentage of patients with recurrent wheezing
timeFrame: 12 Months
measure: Number of days with respiratory tract infection (RTIs) symptoms
timeFrame: 12 Months
measure: Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)
timeFrame: 12 Months
measure: Number of antibiotic cycles
timeFrame: 12 Months
measure: Number of medical visits
timeFrame: 12 Months
measure: Number of days absent from daycare/school
timeFrame: 12 Months
measure: Number of patients with adverse events (AEs)
timeFrame: 12 Months
measure: Number of work days when parents/LAR had to miss work or had their productivity
timeFrame: 12 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Medical Clinic
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Medical Center - University Campus
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research Inc.
state: California
city: Foothill Ranch
country: United States
facility: Hoag Health Center Foothill Ranch
state: California
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland Primary Care Clinic
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics
state: Colorado
city: Coral Gables
country: United States
facility: BioMD Clinical Research
state: Florida
city: Miami
country: United States
facility: C & R Research Services USA. Inc
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Riley Children's Health - Pediatrics
state: Indiana
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists PSC
state: Kentucky
city: Lafayette
country: United States
facility: Velocity Clinical Research - Lafayette
state: Louisiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Binghamton
country: United States
facility: Velocity Clinical Research - Binghamton
state: New York
city: Great Neck
country: United States
facility: Northwell Health/Division of Allergy & Immunology
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals, The Univ of NC at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children'S Hospital Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital
state: Tennessee
city: Houston
country: United States
facility: Helios Clinical Research - Houston
state: Texas
city: Houston
country: United States
facility: La Providence Pediatrics Clinic
state: Texas
city: Mansfield
country: United States
facility: Prime Clinical Research Inc
state: Texas
city: Pflugerville
country: United States
facility: ARC Clinical Research at Kelly Lane
state: Texas
city: San Antonio
country: United States
facility: STAAMP Research
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler - Pulmonology
state: Texas
city: Madison
country: United States
facility: University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine
state: Wisconsin
city: Geelong
country: Australia
facility: University Hospital Geelong - Barwon Health
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Childrens Hospital
state: Victoria
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz
state: Borsod-Abauj-Zemplen
city: Szeged
country: Hungary
facility: Aranyklinika Kft.
state: Csongrad
city: Lodz
country: Poland
facility: WWCOiT im. M. Kopernika w Łodzi, Ośrodek Pediatryczny im dr J. Korczaka Poradnia Alergologiczna
state: Lodzkie
city: Skierniewice
country: Poland
facility: Velocity Skierniewice Sp. z o.o.
state: Lodzkie
city: Tarnów
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o.
state: Malopolskie
city: Bialystok
country: Poland
facility: NZOZ E-Vita
state: Podlaskie
Study officials:
References: