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

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 6
Healthy Volunteers: f
View:

∙ 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 (at current dose or higher).

• 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.

Locations
United States
Arkansas
Arkansas Children's Hospital Research Institute
RECRUITING
Little Rock
Arizona
Arizona Medical Clinic
TERMINATED
Phoenix
Phoenix Children's Hospital
RECRUITING
Phoenix
The University of Arizona Medical Center - University Campus
RECRUITING
Tucson
California
Kern Research Inc.
RECRUITING
Bakersfield
Hoag Health Center Foothill Ranch
RECRUITING
Foothill Ranch
UCSF Benioff Children's Hospital Oakland Primary Care Clinic
RECRUITING
Oakland
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
TERMINATED
San Diego
Rady Children's Hospital
RECRUITING
San Diego
Colorado
Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics
RECRUITING
Aurora
Florida
BioMD Clinical Research
RECRUITING
Coral Gables
C & R Research Services USA. Inc
RECRUITING
Miami
Illinois
Rush University Medical Center
TERMINATED
Chicago
Indiana
Riley Children's Health - Pediatrics
RECRUITING
Indianapolis
Kentucky
Allergy & Asthma Specialists PSC
RECRUITING
Owensboro
Louisiana
Velocity Clinical Research - Lafayette
RECRUITING
Lafayette
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
North Carolina
UNC Hospitals, The Univ of NC at Chapel Hill
RECRUITING
Chapel Hill
New York
Velocity Clinical Research - Binghamton
RECRUITING
Binghamton
Northwell Health/Division of Allergy & Immunology
RECRUITING
Great Neck
Ohio
Cincinnati Children'S Hospital Medical Center
RECRUITING
Cincinnati
Oklahoma
Allergy, Asthma and Clinical Research Center
RECRUITING
Oklahoma City
Vital Prospects Clinical Research Institute, PC
RECRUITING
Tulsa
Tennessee
Monroe Carell Jr. Children's Hospital
RECRUITING
Nashville
Texas
Helios Clinical Research - Houston
RECRUITING
Houston
La Providence Pediatrics Clinic
RECRUITING
Houston
Prime Clinical Research Inc
RECRUITING
Mansfield
ARC Clinical Research at Kelly Lane
WITHDRAWN
Pflugerville
STAAMP Research
RECRUITING
San Antonio
The University of Texas Health Science Center at Tyler - Pulmonology
TERMINATED
Tyler
Wisconsin
University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine
RECRUITING
Madison
Other Locations
Australia
University Hospital Geelong - Barwon Health
RECRUITING
Geelong
The Royal Childrens Hospital
NOT_YET_RECRUITING
Melbourne
Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz
RECRUITING
Miskolc
Aranyklinika Kft.
RECRUITING
Szeged
Poland
NZOZ E-Vita
RECRUITING
Bialystok
WWCOiT im. M. Kopernika w Łodzi, Ośrodek Pediatryczny im dr J. Korczaka Poradnia Alergologiczna
NOT_YET_RECRUITING
Lodz
Velocity Skierniewice Sp. z o.o.
RECRUITING
Skierniewice
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o.
RECRUITING
Tarnów
Contact Information
Primary
Lorenz Lehr
lorenz.lehr@ompharma.com
+41 22 7831459
Time Frame
Start Date: 2023-06-20
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 288
Treatments
Experimental: OM-85
Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.
Placebo_comparator: Placebo
Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.
Related Therapeutic Areas
Sponsors
Leads: OM Pharma SA

This content was sourced from clinicaltrials.gov

Similar Clinical Trials