Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma

This study has been terminated.
(Data from Dose Groups 1,2 and other MN-221 studies resulted in the determination of a more appropriate dosing scheme for MN-221 in subjects with asthma.)
Sponsor:
Information provided by (Responsible Party):
MediciNova
ClinicalTrials.gov Identifier:
NCT00683449
First received: May 21, 2008
Last updated: October 5, 2011
Last verified: October 2011
  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: Dose Group 1
Drug: MN-221 placebo
Drug: Dose Group 2
Drug: Dose Group 3
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:
  • Change of FEV1 (Forced Expiratory Volume in 1 Second) 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: Baseline and Hour 2 ] [ Designated as safety issue: No ]
    The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.


Secondary Outcome Measures:
  • FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second. [ Time Frame: Baseline to Hour 2 ] [ Designated as safety issue: No ]
    FEV1 (L) was determined over time using a spirometer. Measure the mean change in FEV1 (L) from Baseline.

  • Hospital Admission Rate During Visit 1 [ Time Frame: Hour -1.5 through Hour 5 ] [ Designated as safety issue: Yes ]
    After a patient in the emergency department (ED) presents with an acute exacerbation of asthma, the hospital proceeds with SOC procedures for this condition. Despite treatment in the ED, it is sometimes necessary to admit the patient into the hospital. In the study described here, the rate of hospital admissions was recorded.


Enrollment: 29
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV infusion of MN-221
MN-221 total dose of 240 mcg
Drug: Dose Group 1
IV infusion of MN-221 16 mcg/min for 15 min; total dose of 240 mcg
Other Name: bedoradrine
Drug: Dose Group 2
i.v. infusion of MN-221 30 mcg/min for 15 minutes (total dose of 450 mcg)
Other Name: bedoradrine
Drug: Dose Group 3
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)
Other Name: bedoradrine
Placebo Comparator: MN-221 PLACEBO
i.v. infusion of MN-221 Placebo for 15 min
Drug: MN-221 placebo
i.v. infusion of placebo for 15 minutes
Other Name: bedoradrine

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Maricopa Medical Center; Dept. of Emergency Medicine
Phoenix, Arizona, United States, 85008
United States, California
LAC + USC Medical Center
Los Angeles, California, United States, 90033
Olive View - UCLA Medical Center
Sylmar, California, United States, 91342
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48208
United States, Missouri
Washington University School of Medicine; Div. of Emergency Medicine
St. Louis, Missouri, United States, 63110
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
MediciNova
Investigators
Study Director: Michael Kalafer, MD MediciNova
  More Information

No publications provided by MediciNova

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MediciNova
ClinicalTrials.gov Identifier: NCT00683449     History of Changes
Other Study ID Numbers: MN-221-CL-006
Study First Received: May 21, 2008
Results First Received: February 16, 2011
Last Updated: October 5, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 01, 2014