NCT02148796

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 822 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

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.

Detailed description

This is a five year parallel arm, double-blind, placebo-controlled trial for the prevention of WLRI into the third to seventh year of life (30 to 78 mo inclusive) in young children (6-18 months old) at increased risk for asthma. The trial will be divided into 2 periods. During the initial treatment period (first and second years in the study) participants will receive Broncho- Vaxom® (3.5 mg) or placebo for ten days each month for two consecutive years. This period will allow the observation of key secondary outcomes while participants are receiving therapy. The second period (third through fifth years in the study) will be a three year observation of the time to occurrence of the first WLRI episode (primary outcome) while off study drug along with the secondary outcomes noted above. During both the treatment and observation periods, participants will be managed by study physicians using a rescue algorithm applied in the PEAK trial commensurate with the NAEPP Expert Panel Report (EPR) III guidelines.

Conditions

• Asthma
• Wheezing

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2014-05-28
• Last updated: 2026-02-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study