Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma
NCT00683449 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2011-10-07
Summary
The objective of this clinical study is to examine the safety and effectiveness of intravenous MN-221 compared to placebo when administered as an adjunct to standard therapy in subjects experiencing an acute exacerbation of asthma.
Conditions
- Asthma
- Status Asthmaticus
Interventions
- DRUG
-
Dose Group 1
IV infusion of MN-221 16 mcg/min for 15 min; total dose of 240 mcg
- DRUG
-
MN-221 placebo
i.v. infusion of placebo for 15 minutes
- DRUG
-
Dose Group 2
i.v. infusion of MN-221 30 mcg/min for 15 minutes (total dose of 450 mcg)
- DRUG
-
Dose Group 3
i.v. infusion of MN-221 16 mcg/min for 15 minutes followed by 8 mcg/min for 105 minutes (total dose = 1,080 mcg)
Sponsors & Collaborators
-
MediciNova
lead INDUSTRY
Principal Investigators
-
Michael Kalafer, MD · MediciNova
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
Countries
- United States
Study Locations
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