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

Recurrent Wheezing Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857930
• Other study ID #: BV-2020/09
• Status: Recruiting
• Phase: Phase 2
• Start date: June 20, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: December 2023
• Source: OM Pharma SA
• Contact: Lorenz Lehr
• Phone: +41 22 7831459
• Email: lorenz.lehr[@]ompharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: February 28, 2026
• Est. primary completion date: August 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 72 Months

Eligibility

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 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.
• 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.

Related Conditions & MeSH terms

• Recurrence
• Recurrent Wheezing
• Respiratory Sounds

Intervention

Drug:
• OM-85
OM-85 capsule (3.5mg) contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.
• Placebo
Placebo capsule contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics	Aurora	Colorado
United States	Kern Research Inc.	Bakersfield	California
United States	Velocity Clinical Research - Binghamton	Binghamton	New York
United States	Boston Children's Hospital	Boston	Massachusetts
United States	UNC Hospitals, The Univ of NC at Chapel Hill	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Children'S Hospital Medical Center	Cincinnati	Ohio
United States	BioMD Clinical Research	Coral Gables	Florida
United States	Hoag Health Center Foothill Ranch	Foothill Ranch	California
United States	Northwell Health/Division of Allergy & Immunology	Great Neck	New York
United States	Helios Clinical Research - Houston	Houston	Texas
United States	La Providence Pediatrics Clinic	Houston	Texas
United States	Riley Children's Health - Pediatrics	Indianapolis	Indiana
United States	Velocity Clinical Research - Lafayette	Lafayette	Louisiana
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas
United States	University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine	Madison	Wisconsin
United States	Prime Clinical Research Inc	Mansfield	Texas
United States	C & R Research Services USA. Inc	Miami	Florida
United States	Monroe Carell Jr. Children's Hospital	Nashville	Tennessee
United States	UCSF Benioff Children's Hospital Oakland Primary Care Clinic	Oakland	California
United States	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma
United States	Allergy & Asthma Specialists PSC	Owensboro	Kentucky
United States	ARC Clinical Research at Kelly Lane	Pflugerville	Texas
United States	Arizona Medical Clinic	Phoenix	Arizona
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	STAAMP Research	San Antonio	Texas
United States	Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology	San Diego	California
United States	Rady Children's Hospital	San Diego	California
United States	The University of Arizona Medical Center - University Campus	Tucson	Arizona
United States	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma
United States	The University of Texas Health Science Center at Tyler - Pulmonology	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
OM Pharma SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Wheezing/Asthma like episodes (WEs)	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.	6 Months
Secondary	Rate of severe WEs	To assess the efficacy of OM-85 in reducing the rate of severe WEs compared to placebo during the 6-month Treatment period.	6 Months
Secondary	Number of oral corticosteroid (OCS) treatments during 6-month treatment period	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.	6 Months
Secondary	Number of days with WEs	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.	6 Months
Secondary	Rate of WEs and severe WEs	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.	From Month 6 up to Month 12
Secondary	Number of OCS treatments during 6-month observational period	To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs vs. placebo during the 6-month observational period.	From Month 6 up to Month 12
Secondary	Duration in days of WEs and severe WEs	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.	12 Months
Secondary	Time to treatment failure	To assess the efficacy of OM-85 compared to placebo to prolong time to treatment failure, during the whole study period.	12 Months
Secondary	Time to first, second and third WE	To assess the efficacy of OM-85 compared to placebo to prolong the time to first, second, and third WE.	12 Months
Secondary	Number of routine asthma treatment	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.	12 Months
Secondary	Duration of routine asthma treatment	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.	12 Months
Secondary	Percentage of patients with recurrent wheezing	To assess the efficacy of OM-85 compared to placebo in reducing the percentage of patients with =1 WEs during the 6-month treatment period and the 6-month observational period.	12 Months
Secondary	Number of days with respiratory tract infection (RTIs) symptoms	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.	12 Months
Secondary	Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)	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).	12 Months
Secondary	Number of antibiotic cycles	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.	12 Months
Secondary	Number of medical visits	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.	12 Months
Secondary	Number of days absent from daycare/school	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.	12 Months
Secondary	Number of patients with adverse events (AEs)	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.	12 Months