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

PHASE2RecruitingINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

June 20, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Recurrent WheezingWheezing Lower Respiratory Illness
Interventions
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.

DRUG

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.

Trial Locations (39)

3052

NOT_YET_RECRUITING

The Royal Childrens Hospital, Melbourne

3220

RECRUITING

University Hospital Geelong - Barwon Health, Geelong

3526

RECRUITING

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz, Miskolc

6720

RECRUITING

Aranyklinika Kft., Szeged

11021

RECRUITING

Northwell Health/Division of Allergy & Immunology, Great Neck

13905

RECRUITING

Velocity Clinical Research - Binghamton, Binghamton

27514

RECRUITING

UNC Hospitals, The Univ of NC at Chapel Hill, Chapel Hill

33134

RECRUITING

BioMD Clinical Research, Coral Gables

33183

RECRUITING

C & R Research Services USA. Inc, Miami

37821

RECRUITING

Monroe Carell Jr. Children's Hospital, Nashville

42301

RECRUITING

Allergy & Asthma Specialists PSC, Owensboro

46202

RECRUITING

Riley Children's Health - Pediatrics, Indianapolis

60612

TERMINATED

Rush University Medical Center, Chicago

70508

RECRUITING

Velocity Clinical Research - Lafayette, Lafayette

72202

RECRUITING

Arkansas Children's Hospital Research Institute, Little Rock

73120

RECRUITING

Allergy, Asthma and Clinical Research Center, Oklahoma City

74136

RECRUITING

Vital Prospects Clinical Research Institute, PC, Tulsa

76063

RECRUITING

Prime Clinical Research Inc, Mansfield

77008

RECRUITING

Helios Clinical Research - Houston, Houston

77071

RECRUITING

La Providence Pediatrics Clinic, Houston

78229

RECRUITING

STAAMP Research, San Antonio

78660

WITHDRAWN

ARC Clinical Research at Kelly Lane, Pflugerville

85015

TERMINATED

Arizona Medical Clinic, Phoenix

85016

RECRUITING

Phoenix Children's Hospital, Phoenix

85724

RECRUITING

The University of Arizona Medical Center - University Campus, Tucson

92123

TERMINATED

Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology, San Diego

RECRUITING

Rady Children's Hospital, San Diego

92610

RECRUITING

Hoag Health Center Foothill Ranch, Foothill Ranch

93301

RECRUITING

Kern Research Inc., Bakersfield

94618

RECRUITING

UCSF Benioff Children's Hospital Oakland Primary Care Clinic, Oakland

80045-7106

RECRUITING

Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics, Aurora

02115

RECRUITING

Boston Children's Hospital, Boston

45229-3039

RECRUITING

Cincinnati Children'S Hospital Medical Center, Cincinnati

75708-3154

TERMINATED

The University of Texas Health Science Center at Tyler - Pulmonology, Tyler

53792-9988

RECRUITING

University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine, Madison

33-100

RECRUITING

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o., Tarnów

15-879

RECRUITING

NZOZ E-Vita, Bialystok

90-329

NOT_YET_RECRUITING

WWCOiT im. M. Kopernika w Łodzi, Ośrodek Pediatryczny im dr J. Korczaka Poradnia Alergologiczna, Lodz

96-100

RECRUITING

Velocity Skierniewice Sp. z o.o., Skierniewice

Sponsors

Lead Sponsor

All Listed Sponsors
lead

OM Pharma SA

INDUSTRY

NCT05857930 - A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing | Biotech Hunter | Biotech Hunter