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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: RNS60; Drug: Placebo

• Registration Number: NCT02422121
• Lead Sponsor: Revalesio Corporation

Brief 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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-07
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RNS60	RNS60	RNS60, 4 ml twice daily
Placebo	Placebo	Normal Saline, 4 ml twice daily

Primary Outcome Measures

Name	Time	Method
Change in late asthmatic response (LAR) as measured by spirometry	Baseline and Day 21	The maximal percentage decrease from the pre-allergen challenge (post-diluent value) in FEV1 between 3 hours and 8 hours post-allergen challenge.

Trial Locations

Locations (1)

Quintiles Drug Research Unit at Guy's Hospital; 🇬🇧 London, United Kingdom