NCT01316315

Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

A Double-Blind, Randomized, Placebo-Controlled, Two-Period, Cross-Over Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Nivalis Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a single IV dose of N6022 will have a significant bronchoprotective effect, compared with placebo, during methacholine challenge.

Detailed description

The number of patients with adverse events measured in both the treated and placebo groups from start of dosing until Day 28 post dose.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Active	A 5 mg single dose given intravenously via syringe pump over 1 minute.
DRUG	Placebo	Same as active

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-03-16
• Last updated: 2014-05-05
• Results posted: 2014-03-11

Locations

2 sites across 1 country: United States