ACTIVE_NOT_RECRUITING

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

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Conditions

Recurrent WheezingWheezing Lower Respiratory IllnessInnate immune responseType 1 immune responseType 2 immune responseBacterial lysateImmunomodulationEAGLE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-06-20
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05857930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 72 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children of either gender, aged between 6 and 72 months (5 years inclusive).
  2. * Children with recurrent wheezing:
  3. * 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.
  4. * 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).
  5. * Up-to-date vaccination status as per applicable State or country Vaccination Requirements for school/day-care entry.
  6. * 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.
  1. * Known anatomic alterations of the respiratory tract.
  2. * Wheezing documented to be caused by gastroesophageal reflux.
  3. * Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).
  4. * Any known autoimmune disease.
  5. * Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency).
  6. * Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities.
  7. * Children born prematurely i.e., before 34 weeks of gestational age.
  8. * 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.
  9. * Any known neoplasia or malignancy.
  10. * Treatment with the following medications:
  11. * Systemic corticosteroids within 4 weeks before study enrollment.
  12. * Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment.
  13. * Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
  14. * Known allergy or previous intolerance to investigational drug.
  15. * Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
  16. * Other household members have previously been randomized in this clinical study and have not completed their 6-month treatment period.
  17. * Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
  18. * Currently enrolled in or has completed any other investigational device or drug study \<30 days prior to screening or receiving other investigational agent(s).

Contacts and Locations

Study Locations (Sites)

Arizona Medical Clinic
Phoenix, Arizona, 85015
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
The University of Arizona Medical Center - University Campus
Tucson, Arizona, 85724
United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
United States
Kern Research Inc.
Bakersfield, California, 93301
United States
Hoag Health Center Foothill Ranch
Foothill Ranch, California, 92610
United States
UCSF Benioff Children's Hospital Oakland Primary Care Clinic
Oakland, California, 94618
United States
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
San Diego, California, 92123
United States
Rady Children's Hospital
San Diego, California, 92123
United States
Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics
Aurora, Colorado, 80045-7106
United States
BioMD Clinical Research
Coral Gables, Florida, 33134
United States
C & R Research Services USA. Inc
Miami, Florida, 33183
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Riley Children's Health - Pediatrics
Indianapolis, Indiana, 46202
United States
Allergy & Asthma Specialists PSC
Owensboro, Kentucky, 42301
United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Velocity Clinical Research - Binghamton
Binghamton, New York, 13905
United States
Northwell Health/Division of Allergy & Immunology
Great Neck, New York, 11021
United States
UNC Hospitals, The Univ of NC at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, 45229-3039
United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
United States
Monroe Carell Jr. Children's Hospital
Nashville, Tennessee, 37821
United States
Helios Clinical Research - Houston
Houston, Texas, 77008
United States
La Providence Pediatrics Clinic
Houston, Texas, 77071
United States
Prime Clinical Research Inc
Mansfield, Texas, 76063
United States
STAAMP Research
San Antonio, Texas, 78229
United States
The University of Texas Health Science Center at Tyler - Pulmonology
Tyler, Texas, 75708-3154
United States
University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine
Madison, Wisconsin, 53792-9988
United States

Collaborators and Investigators

Sponsor: OM Pharma SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-20
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Innate immune response
  • Type 1 immune response
  • Type 2 immune response
  • Bacterial lysate
  • Immunomodulation
  • EAGLE

Additional Relevant MeSH Terms

  • Recurrent Wheezing
  • Wheezing Lower Respiratory Illness