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Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma

NCT01511302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-07-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.

Conditions

Interventions

DRUG

RNS60

RNS60, 2ml, nebulized twice daily.

DRUG

Normal Saline

Normal Saline placebo, 2 ml, nebulized twice daily.

DRUG

Budesonide

Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS.

Sponsors & Collaborators

  • Revalesio Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511302 on ClinicalTrials.gov