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| Sponsor: | MediciNova |
|---|---|
| Information provided by: | MediciNova |
| ClinicalTrials.gov Identifier: | NCT00683449 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Status Asthmaticus |
Drug: MN-221 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Randomized, Modified Single-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously as an Adjunct to Standard Therapy to Adults With an Acute Exacerbation of Asthma |
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
MN-221
|
Drug: MN-221
Dose Level 1: 16 μg/min continuous infusion of MN-221 for 15 minutes (total dose of 240 μg) or MN-221 Placebo; Dose Level 2: 30 μg/min continuous infusion for 15 minutes (total dose of 450 μg) or MN-221 Placebo; Dose Level 3: 16 μg/min continuous infusion for 15 minutes followed by 8 μg/min for 105 minutes (total dose of 1,080 μg) or MN-221 Placebo |
|
2: Placebo Comparator
MN-221 Placebo
|
Drug: MN-221
Dose Level 1: 16 μg/min continuous infusion of MN-221 for 15 minutes (total dose of 240 μg) or MN-221 Placebo; Dose Level 2: 30 μg/min continuous infusion for 15 minutes (total dose of 450 μg) or MN-221 Placebo; Dose Level 3: 16 μg/min continuous infusion for 15 minutes followed by 8 μg/min for 105 minutes (total dose of 1,080 μg) or MN-221 Placebo |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Upon presentation to the ED the treatment provided included:
Exclusion criteria:
Contacts and Locations| Contact: Carol Conlin, RN | 858-320-0544 |
| United States, Arizona | |
| Maricopa Medical Center; Dept. of Emergency Medicine | Recruiting |
| Phoenix, Arizona, United States, 85008 | |
| Principal Investigator: Frank LoVecchio, DO | |
| United States, California | |
| LAC + USC Medical Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: Sean O Henderson, MD | |
| Olive View - UCLA Medical Center | Recruiting |
| Sylmar, California, United States, 91342 | |
| Principal Investigator: Luis M Lovato, MD | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48208 | |
| Principal Investigator: Richard Nowak, MD, MBA | |
| United States, Missouri | |
| Washington University School of Medicine; Div. of Emergency Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: Lawrence Lewis, MD | |
| United States, New York | |
| Long Island Jewish Medical Center | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Principal Investigator: Gino Farina, MD | |
| New York Methodist Hospital | Recruiting |
| Brooklyn, New York, United States, 11215 | |
| Principal Investigator: Robert Birkhahn, MD | |
| United States, Ohio | |
| MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Principal Investigator: Rita K Cydulka, MD | |
| United States, Pennsylvania | |
| Albert Einstein Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Principal Investigator: John J Kelly, DO | |
| Study Director: | Michael Kalafer, MD | MediciNova |
More Information
| Responsible Party: | MediciNova ( Michael Kalafer, MD, Medical Director ) |
| Study ID Numbers: | MN-221-CL-006 |
| Study First Received: | May 21, 2008 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00683449 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Dose-Escalation Controlled MN-221 |
|
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Status Asthmaticus Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |