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COMPLETED
NCT02148796
PHASE2

Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness

Sponsor: University of Arizona

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk infants for 10 days, monthly, for two consecutive years can increase time to occurrence of the first episode of wheezing lower respiratory tract illness (WLRI) during a three year observation period off therapy.

Official title: Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)

Key Details

Gender

All

Age Range

6 Months - 18 Months

Study Type

INTERVENTIONAL

Enrollment

822

Start Date

2017-01-01

Completion Date

2026-01-30

Last Updated

2026-06-02

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Broncho-Vaxom (BV)

Active Ingredient: Lyophilised bacterial extract; Chemical Name: OM-85 BV; Strength: 3.5 mg; Excipients: bacterial extract, propyl gallate, sodium glutamate, mannitol, pregelatinised starch, magnesium stearate; Appearance: Blue and white capsule; Dosage Form: 3.5 mg capsule; Manufacturer: OM Pharma, Switzerland (OM stands for Omnia Medicamenta) Storage: Store in the original package

OTHER

Placebo

A placebo capsule will be used that will be indistinguishable from the active study drug.

Locations (11)

Phoenix Children's Hospital

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of California San Francisco, Benioff Children's Hospital

Oakland, California, United States

Children's National Health System

Washington D.C., District of Columbia, United States

Emory University

Atlanta, Georgia, United States

Boston Children's Hospital, Harvard University

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Columbia University

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital & Medical Center

Cincinnati, Ohio, United States

University of Wisconsin

Madison, Wisconsin, United States