drugset / Trial / NCT00838591
Study Evaluating the Safety and Efficacy of MN-221 as an Adjunct to Standard Therapy in Subjects Experiencing an Acute Exacerbation of Asthma
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-03
- Primary completion
- 2012-03
- Completion
- 2012-03
Outcome
Missed primary endpoint
paper There was no significant difference in %FEV1 at 3 h between the 2 groups. PMID 26324315 ↗
Publications
- House SL, Matsuda K, O'Brien G, Makhay M, Iwaki Y, Ferguson I, Lovato LM, Lewis LM. Efficacy of a new intravenous beta2-adrenergic agonist (bedoradrine, MN-221) for patients with an acute exacerbation of asthma. Respir Med. 2015 Oct;109(10):1268-73. doi: 10.1016/j.rmed.2015.08.003. Epub 2015 Aug 14.
- Schneider JE, Lewis LM, Ferguson I, House SL, Liu J, Matsuda K, Johnson K. Repeated dyspnea score and percent FEV1 are modest predictors of hospitalization/relapse in patients with acute asthma exacerbation. Respir Med. 2014 Sep;108(9):1284-91. doi: 10.1016/j.rmed.2014.06.006. Epub 2014 Jul 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bedoradrine | Small molecule | 1200 ug | Intravenous |