NCT02422121

Effect of RNS60 on the Late Phase Asthmatic Response to Allergen Challenge

A Phase IIa Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Multiple Doses of Inhaled RNS60 and Budesonide on the Late Phase Asthmatic Response to Allergen Challenge in Patients With Mild Asthma. (This Study Has Been Amended to no Longer be a Cross Over Study; it Will be a Parallel (RNS60/Placebo) 1 Period Study and no Longer Involves the Administration of Budesonide)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Revalesio Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1 will be measured after an inhaled allergen challenge at baseline and again after 21 days of treatment.

Detailed description

This is a randomized, placebo-controlled, parallel study in approximately 32 male and female subjects with mild asthma. Each subject will receive either the experimental or the placebo, administered as a nebulized dose twice daily for 21 days.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	RNS60
DRUG	Placebo

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-04-21
• Last updated: 2016-12-09

Locations

1 site across 1 country: United Kingdom