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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
176
Loma Linda University Medical Center
Loma Linda, California, United States
UCSD Medical Center - Thornton Hospital
San Diego, California, United States
The primary efficacy analysis will be based on a change in FEV1, expressed as percent of predicted, at Hour 3 when compared to FEV1, expressed as percent of predicted, at the qualifying/screening timepoint.
Time frame: Hour 3
Change from baseline FEV1 % of predicted (at time points other than Hour 3)
Time frame: Hours 1, 2, 3, and 24
Change from baseline FEV1 (L)
Time frame: Hours 1, 2, 3 and 24
Change from baseline PEFR (L/sec)
Time frame: Hours 1, 2, 3 and 24
Change from baseline PEFR, expressed as percent (%) of predicted
Time frame: Hours 1, 2, 3and 24
Improvement in Dyspnea index scale
Time frame: Hours 1, 2, 3, 24 and Day 8
Percent of subjects with an improvement in FEV1 ≥ 200cc
Time frame: Hours 1, 2, 3 and 24
Percent of subjects with an improvement in FEV1, % predicted ≥ 5%
Time frame: Hours 1, 2, 3 and 24
Percent of subjects with and improvement in FEV1, % predicted ≥ 10%
Time frame: Hours 1, 2, 3 and 24
Subjects Hospitalized ( within 24 hour from start of study drug infusion)
Time frame: Within 24 hours from start of study drug infusion.
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UCSD Medical Center
San Diego, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
Newton - Wellesley Hospital
Newton, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
...and 5 more locations
Admitted to ICU (within 24 hours from start of study drug infusion)
Time frame: Within 24 hours from start of study drug infusion.
Number of albuterol treatments to achieve an increase in FEV1% of predicted ≥ 15%
Time frame: Hours 3
Total dose or number of albuterol treatments in first 3 hours following commencement of randomized medication.
Time frame: No specific time points
Time to achieve an increase of FEV1% of predicted ≥ 15%
Time frame: No specific time points
Time to initial albuterol treatment following the commencement of randomized medication
Time frame: No specific time points
Hospital length of stay
Time frame: No specific timepoints