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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 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. The trial reports 20 study locations across 11 states.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05857930
The ClinicalTrials.gov registry entry for NCT05857930 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OM Pharma, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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