Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma
Condition: Asthma; Status Asthmaticus
MeSH terms: Asthma; Status Asthmaticus
Intervention: Dose Group 1; MN-221 placebo; Dose Group 2; Dose Group 3
Intervention description: IV infusion of MN-221 16 mcg/min for 15 min; total dose of 240 mcg; i.v. infusion of placebo for 15 minutes; i.v. infusion of MN-221 30 mcg/min for 15 minutes (total dose of 450 mcg); 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)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Asthma; Dose-Escalation; Controlled; MN-221

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female;

          2. Have self-reported history of physician-diagnosed and treated asthma for ≥ 3 months;

          3. Have a diagnosis of an acute exacerbation of asthma upon presentation at the ED as
             defined by dyspnea and evidence of bronchospasm in an individual with a known history
             of asthma;

          4. Upon presentation to the ED the treatment provided included:

               -  A brief history and physical examination that includes vital signs, auscultation,
                  assessments of accessory respiratory muscle usage and the level of dyspnea the
                  subject is experiencing;

               -  Supplemental oxygen given to maintain oxygen saturation as measured by pulse
                  oximetry of ≥ 90%;

               -  Two doses of inhaled beta2-agonist (defined as albuterol 5 mg) via nebulizer
                  (each dose given sequentially up to approximately every 20 minutes);
                  simultaneously with

               -  Two doses of an inhaled anti-cholinergic agent (defined as ipratropium 0.5 mg)
                  via nebulizer (each dose given sequentially up to approximately every20 minutes);

               -  One dose of corticosteroid of at least 60 mg given orally (prednisone) or
                  intravenously (methylprednisolone); and

          5. Have a FEV1 ≤ 55% within 10 minutes of completing the treatment described in Inclusion
             Criterion #4;

          6. Have a negative urine pregnancy test if you are females of childbearing potential;

          7. Have ECG with no dysrhythmias (except sinus tachycardia);

          8. Have no clinical or electrocardiographic signs of ischemic heart disease as determined
             by the Investigator; and

          9. Have signed the informed consent obtained prior to starting any study procedures.

        Exclusion criteria:

          1. Have a current or prior diagnosis or suspected diagnosis of COPD or other chronic lung
             disease other than asthma;

          2. Have presence of pneumonia;

          3. Have presence of significant other respiratory dysfunction such as pneumothorax,
             pneumomediastinum, or pulmonary edema;

          4. Have known or suspected vocal cord dysfunction syndrome;

          5. Have presence of aspirated foreign body (known or suspected);

          6. Have a history or any current clinical evidence suggesting cardiomyopathy or
             congestive heart failure;

          7. Have a history or presence of tachyarrhythmias, with the exception of sinus
             tachycardia;

          8. Have a heart rate ≥ maximum heart rate: (maximum predicted HR [220-age]-30); OR Heart
             rate ≥ 150 bpm;

          9. Have hypokalemia, defined as a potassium level ≤ 3.0 mg/dL according to the
             point-of-care device level obtained at Screening;

         10. Have significant cardiac, renal, hepatic, endocrine, metabolic, neurologic or other
             systemic disease. A significant disease will be defined as one which, in the opinion
             of the Investigator, may either put the subject at risk because of participation in
             the study, or may influence the results of the study or the subject's ability to
             participate in the trial;

         11. Have a self-reported history of greater than 15 pack-yr smoking history;

         12. Have a fever ≥ 101.5º F;

         13. Have uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg;

         14. Have the need for immediate intubation as determined by the Investigator;

         15. Are a pregnant or lactating female;

         16. Have participated in another clinical study with an investigational drug within 30
             days of randomization;

         17. Have a positive urine drug screen for cocaine, methamphetamine or PCP;

         18. Have a known allergy to MN-221 or any of the other components of the MN-221 drug
             product ;

         19. Have a known allergy to other beta agonists;

         20. Have had previous exposure to MN-221; or

         21. Have used of theophylline, beta blockers, diuretics, digoxin, MAO inhibitors, or
             tricyclic antidepressants within 2 weeks prior to randomization.