Trials / Completed
CompletedNCT01511302
Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma
A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Revalesio Corporation · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2013-04-01
- Completion
- 2013-05-01
- First posted
- 2012-01-18
- Last updated
- 2014-07-28
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01511302. Inclusion in this directory is not an endorsement.