Study Evaluating the Safety and Efficacy of MN-221 as an Adjunct to Standard Therapy in Subjects Experiencing an Acute Exacerbation of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is an international, randomized, double-blind, placebo-controlled, multi-center ED
      study. Each subject will receive MN-221 or placebo administered through a continuous
      intravenous infusion in addition to the standardized treatment for an acute exacerbation of
      asthma.

      Upon presentation to the ED for assessment and treatment for an acute exacerbation of asthma
      the patient should receive standard of care consistent with the international guidelines
      (e.g., Global Initiative for Asthma [GINA] or the National Asthma Education and Prevention
      Program [NAEPP]) and required, in part, by this protocol prior to screening procedures being
      performed.

      Prior to any study specific treatment or evaluation being performed a subject must have
      signed an IRB/EC/REB approved consent form. Once the subject has received the initial
      treatment regimen the subject will be assessed for response to the treatment including
      spirometry.If the subject meets all entry criteria the subject will be randomized to receive
      MN-221 or placebo. Throughout the screening process the subject will continue to receive
      standardized treatment consistent with the appropriate guidelines for the treatment of acute
      exacerbations of asthma.

      Subjects enrolled in the study will receive an intravenous 1-hour infusion of MN-221 study
      drug or placebo. Subjects receiving MN-221 will be administered a total dose of 1200 μg.

      During the study treatment period, the subject may continue to receive standardized treatment
      and be assessed. The study treatment period will be approximately 3 hours in length. Safety
      and efficacy will be monitored throughout the treatment period. PK parameters (if applicable)
      will be obtained from subjects at selected study sites. A blood sample for genomic evaluation
      will be collected during the treatment period (at participating sites) if the subject
      consents to the evaluation. An initial 24-hour post-randomization follow-up visit will be
      completed to evaluate the subject's health status as well as for safety and PK parameters (if
      applicable). A second follow-up contact will be completed by telephone seven days
      post-randomization for safety purposes and to evaluate the subject's health status.

      A periodic risk/benefit evaluation will be performed by the study's Data Safety Monitoring
      Board.
    

Intervention name(s): MN-221; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo.
Other intervention name(s): bedoradrine sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MN-221; Asthma; Acute; Exacerbation