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Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma
This study is currently recruiting participants.
Verified by MediciNova, February 2009
First Received: May 21, 2008   Last Updated: February 3, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by MediciNova:

Primary Outcome Measures:
  • The primary objective is to determine the change of FEV1 expressed as percent of predicted after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) when compared to FEV1 at Hour 2 after the start of the infusion of MN-221 or placebo. [ Time Frame: Hour 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety, tolerability, and pharmacokinetic profile of MN-221 when administered after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) in subjects with acute exacerbation of asthma. [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  • FEV1 % of predicted at time points other than Hour 2 [ Time Frame: Hours 1, 3, 4, 5, and 24 ] [ Designated as safety issue: No ]
  • FEV1 (L) [ Time Frame: Hours 1, 3, 4, 5, and 24 ] [ Designated as safety issue: No ]
  • PEFR (L/sec) [ Time Frame: Hours 1, 3, 4, 5, and 24 ] [ Designated as safety issue: No ]
  • PEFR, expressed as percent (%) of predicted [ Time Frame: Hours 1, 3, 4, 5, and 24 ] [ Designated as safety issue: No ]
  • Dyspnea index scale [ Time Frame: Hours 1, 2, 3, 4, 5, 24, and Day 8 ] [ Designated as safety issue: No ]
  • Number of albuterol treatments to achieve FEV1 ≥ 50% [ Time Frame: No specific time points ] [ Designated as safety issue: No ]
  • Number of albuterol treatments to achieve FEV1 ≥ 70% [ Time Frame: No specific time points ] [ Designated as safety issue: No ]
  • Time to achieve FEV1 ≥ 50% [ Time Frame: No specific time points ] [ Designated as safety issue: No ]
  • Time to achieve FEV1 ≥ 70%; [ Time Frame: No specific time points ] [ Designated as safety issue: No ]
  • Hospital admission rate [ Time Frame: No specific time points ] [ Designated as safety issue: No ]
  • Hospital length of stay (in hours) [ Time Frame: No specific time points ] [ Designated as safety issue: No ]
  • ICU admission rate [ Time Frame: No specific time points ] [ Designated as safety issue: No ]

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683449

Contacts
Contact: Carol Conlin, RN 858-320-0544

Locations
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            
Sponsors and Collaborators
MediciNova
Investigators
Study Director: Michael Kalafer, MD MediciNova
  More Information

No publications provided

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

Keywords provided by MediciNova:
Asthma
Dose-Escalation
Controlled
MN-221

Additional relevant MeSH terms:
Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Status Asthmaticus
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 09, 2009