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NCT05857930 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing
A Phase 2 study of Recurrent Wheezing and Wheezing Lower Respiratory Illness, sponsored by OM Pharma.
- Active
- Registry status
- Phase 2
- Development phase
- 296
- Enrollment target
- 20
- Study locations
NCT05857930: Active Phase 2 study of Recurrent Wheezing and Wheezing Lower Respiratory Illness, sponsored by OM Pharma.
NCT05857930 is a Phase 2 study of Recurrent Wheezing and Wheezing Lower Respiratory Illness that is active but no longer recruiting, run by OM Pharma. The registered enrollment target is 296 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05857930, a Phase 2 study of Recurrent Wheezing and Wheezing Lower Respiratory Illness, is active but no longer recruiting, sponsored by OM Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 296 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OM-85
Study Locations (20)
California
- Kern Research Inc. - Bakersfield
- Hoag Health Center Foothill Ranch - Foothill Ranch
- UCSF Benioff Children's Hospital Oakland Primary Care Clinic - Oakland
- Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology - San Diego
- Rady Children's Hospital - San Diego
Arizona
- Arizona Medical Clinic - Phoenix
- Phoenix Children's Hospital - Phoenix
- The University of Arizona Medical Center - University Campus - Tucson
Florida
- BioMD Clinical Research - Coral Gables
- American Research Institute, INC - Cutler Bay
- C & R Research Services USA. Inc - Miami
New York
- Velocity Clinical Research - Binghamton - Binghamton
- Northwell Health/Division of Allergy & Immunology - Great Neck
Arkansas
- Arkansas Children's Hospital Research Institute - Little Rock
Colorado
- Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics - Aurora
Illinois
- Rush University Medical Center - Chicago
Indiana
- Riley Children's Health - Pediatrics - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2023-06-20 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What the registry record for NCT05857930 still lists
NCT05857930 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 2 conditions, with Recurrent Wheezing appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05857930 names 20 study sites across 11 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05857930 about?
NCT05857930 is a clinical study titled "A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing". 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
What is the current status of trial NCT05857930?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2023-06-20. Estimated completion is 2026-09-30.
What conditions does trial NCT05857930 study?
This clinical trial studies the following conditions: Recurrent Wheezing, Wheezing Lower Respiratory Illness.
What interventions are being tested in trial NCT05857930?
The interventions under investigation include: Placebo (DRUG), OM-85 (DRUG).
Who is sponsoring clinical trial NCT05857930?
This trial is sponsored by OM Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05857930 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05857930's enrollment target sits among peer trials
296 189th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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