A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing
- Conditions
- Recurrent WheezingWheezing Lower Respiratory Illness
- Interventions
- Drug: Placebo
- Registration Number
- NCT05857930
- Lead Sponsor
- OM Pharma SA
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 288
Subjects who meet all the following criteria will be included in the study:
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Children of either gender, aged between 6 and 72 months (5 years inclusive).
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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.
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Up-to-date vaccination status as per applicable State or country Vaccination Requirements for school/day-care entry.
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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.
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Known anatomic alterations of the respiratory tract.
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Wheezing documented to be caused by gastroesophageal reflux.
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Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).
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Any known autoimmune disease.
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Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency).
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Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities.
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Children born prematurely i.e., before 34 weeks of gestational age.
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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.
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Any known neoplasia or malignancy.
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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.
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Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
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Known allergy or previous intolerance to investigational drug.
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Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
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Other household members have previously been randomized in this clinical study.
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Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OM-85 OM-85 Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months. Placebo Placebo Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.
- Primary Outcome Measures
Name Time Method Rate of Wheezing/Asthma like episodes (WEs) 6 Months To assess the efficacy of OM-85 in reducing the rate of WEs compared to placebo during the 6-month Treatment period in children aged 6 months to 5 years with previous recurrent WEs.
- Secondary Outcome Measures
Name Time Method Number of medical visits 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the number of medical visits (hospitalizations, visits to emergency rooms, or to a physician/health care provider) due to respiratory events during the 6-month treatment period and the 6-month observational period.
Rate of WEs and severe WEs From Month 6 up to Month 12 To assess the efficacy of OM-85 compared to placebo in reducing the rate of WEs and severe WEs during the 6-month Observational period.
Number of WE requiring OCS treatments during 6-month observational period From Month 6 up to Month 12 To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs vs. placebo during the 6-month observational period.
Percentage of patients with recurrent wheezing 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the percentage of patients with ≥1 WEs and ≥2 WEs during the 6-month treatment period and the 6-month observational period.
Number of days absent from daycare/school 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.
Number of patients with adverse events (AEs) 12 Months To assess 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 6-month observational period.
Rate of severe WEs 6 Months To assess the efficacy of OM-85 in reducing the rate of severe WEs compared to placebo during the 6-month Treatment period.
Number of WE requiring oral corticosteroid (OCS) treatment during 6-month treatment period 6 Months To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs compared to placebo during the 6-month Treatment period.
Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe) 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the severity of RTI symptoms during the 6-month treatment period and the 6-month observational period. RTI symptoms severity will be assessed based on the symptom evaluation in the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K), other relevant symptoms indicative of an RTI (e.g., headache, body aches), and tympanic temperature as recorded by patient's parents or legally authorized representative (LAR). Severity of symptoms will be determined by using the following definitions: child does not have this = absent (no sign/symptom evident); a little bad = mild (sign/symptom clearly present but easily tolerated); bad = moderate (definite awareness of sign/symptom that is bothersome but tolerable); and very bad = severe (sign/symptom that is hard to tolerate and causes interference with activities of daily life and/or sleeping).
Number of days with WEs 6 Months To assess the efficacy of OM-85 to decrease the cumulative number of days with WEs compared to placebo during the 6-month Treatment period.
Time to first, second and third WE 12 Months To assess the efficacy of OM-85 compared to placebo to prolong the time to first, second, and third WE.
Number of antibiotic cycles 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the antibiotics treatment for an RTI during the 6-month treatment period and the 6-month observational period.
Number of routine asthma treatment 12 Months To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The number of routine asthma treatment will be assessed.
Duration of routine asthma treatment 12 Months To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The duration of routine asthma treatment will be assessed.
Number of work days when parents/LAR had to miss work or had their productivity 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.
Duration in days of WEs and severe WEs 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the duration of WEs and of severe WEs during the 6-month Treatment period and the 6-month Observational period.
Time to treatment failure 12 Months To assess the efficacy of OM-85 compared to placebo to prolong time to treatment failure, during the whole study period.
Number of days with respiratory tract infection (RTIs) symptoms 12 Months To assess the efficacy of OM-85 compared to placebo in reducing the number of days with RTI symptoms during the 6-month treatment period and the 6-month observational period.
Trial Locations
- Locations (39)
Rady Children's Hospital
🇺🇸San Diego, California, United States
University Hospital Geelong - Barwon Health
🇦🇺Geelong, Victoria, Australia
The Royal Childrens Hospital
🇦🇺Melbourne, Victoria, Australia
Arizona Medical Clinic
🇺🇸Phoenix, Arizona, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
The University of Arizona Medical Center - University Campus
🇺🇸Tucson, Arizona, United States
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Kern Research Inc.
🇺🇸Bakersfield, California, United States
Hoag Health Center Foothill Ranch
🇺🇸Foothill Ranch, California, United States
UCSF Benioff Children's Hospital Oakland Primary Care Clinic
🇺🇸Oakland, California, United States
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
🇺🇸San Diego, California, United States
Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics
🇺🇸Aurora, Colorado, United States
BioMD Clinical Research
🇺🇸Coral Gables, Florida, United States
C & R Research Services USA. Inc
🇺🇸Miami, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Riley Children's Health - Pediatrics
🇺🇸Indianapolis, Indiana, United States
Allergy & Asthma Specialists PSC
🇺🇸Owensboro, Kentucky, United States
Velocity Clinical Research - Lafayette
🇺🇸Lafayette, Louisiana, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Velocity Clinical Research - Binghamton
🇺🇸Binghamton, New York, United States
Northwell Health/Division of Allergy & Immunology
🇺🇸Great Neck, New York, United States
UNC Hospitals, The Univ of NC at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, PC
🇺🇸Tulsa, Oklahoma, United States
Monroe Carell Jr. Children's Hospital
🇺🇸Nashville, Tennessee, United States
Helios Clinical Research - Houston
🇺🇸Houston, Texas, United States
La Providence Pediatrics Clinic
🇺🇸Houston, Texas, United States
Prime Clinical Research Inc
🇺🇸Mansfield, Texas, United States
ARC Clinical Research at Kelly Lane
🇺🇸Pflugerville, Texas, United States
STAAMP Research
🇺🇸San Antonio, Texas, United States
The University of Texas Health Science Center at Tyler - Pulmonology
🇺🇸Tyler, Texas, United States
University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine
🇺🇸Madison, Wisconsin, United States
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz
🇭🇺Miskolc, Borsod-Abauj-Zemplen, Hungary
Aranyklinika Kft.
🇭🇺Szeged, Csongrad, Hungary
WWCOiT im. M. Kopernika w Łodzi, Ośrodek Pediatryczny im dr J. Korczaka Poradnia Alergologiczna
🇵🇱Lodz, Lodzkie, Poland
Velocity Skierniewice Sp. z o.o.
🇵🇱Skierniewice, Lodzkie, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o.
🇵🇱Tarnów, Malopolskie, Poland
NZOZ E-Vita
🇵🇱Bialystok, Podlaskie, Poland