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

NCT00683449 | Terminated Phase 2 Results

• 1 other identifier: MN-221-CL-006
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Asthma; Status Asthmaticus

Keywords

Asthma; Dose-Escalation; Controlled; MN-221

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline and Hour 2

Secondary Outcomes (2)

• FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second.

  Baseline to Hour 2

• Hospital Admission Rate During Visit 1

  Hour -1.5 through Hour 5

Study Arms (2)

IV infusion of MN-221

EXPERIMENTAL

MN-221 total dose of 240 mcg

Drug: Dose Group 1; Drug: Dose Group 2; Drug: Dose Group 3

MN-221 PLACEBO

PLACEBO COMPARATOR

i.v. infusion of MN-221 Placebo for 15 min

Drug: MN-221 placebo

Interventions

Dose Group 1 DRUG

IV infusion of MN-221 16 mcg/min for 15 min; total dose of 240 mcg

Also known as: bedoradrine

IV infusion of MN-221

MN-221 placebo DRUG

i.v. infusion of placebo for 15 minutes

Also known as: bedoradrine

MN-221 PLACEBO

Dose Group 2 DRUG

i.v. infusion of MN-221 30 mcg/min for 15 minutes (total dose of 450 mcg)

Also known as: bedoradrine

IV infusion of MN-221

Dose Group 3 DRUG

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)

Also known as: bedoradrine

IV infusion of MN-221

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female;
• Have self-reported history of physician-diagnosed and treated asthma for ≥ 3 months;
• 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;
• 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
• Have a negative urine pregnancy test if you are females of childbearing potential;
• Have ECG with no dysrhythmias (except sinus tachycardia);
• Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator; and
• Have signed the informed consent obtained prior to starting any study procedures.

You may not qualify if:

• Have a current or prior diagnosis or suspected diagnosis of COPD or other chronic lung disease other than asthma;
• Have presence of pneumonia;
• Have presence of significant other respiratory dysfunction such as pneumothorax, pneumomediastinum, or pulmonary edema;
• Have known or suspected vocal cord dysfunction syndrome;
• Have presence of aspirated foreign body (known or suspected);
• Have a history or any current clinical evidence suggesting cardiomyopathy or congestive heart failure;
• Have a history or presence of tachyarrhythmias, with the exception of sinus tachycardia;
• Have a heart rate ≥ maximum heart rate: (maximum predicted HR \[220-age\]-30); OR Heart rate ≥ 150 bpm;
• Have hypokalemia, defined as a potassium level ≤ 3.0 mg/dL according to the point-of-care device level obtained at Screening;
• 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;
• Have a self-reported history of greater than 15 pack-yr smoking history;
• Have a fever ≥ 101.5º F;
• Have uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg;
• Have the need for immediate intubation as determined by the Investigator;
• Are a pregnant or lactating female;

Sponsors & Collaborators

• MediciNova: lead

Study Sites (9)

Maricopa Medical Center; Dept. of Emergency Medicine

Phoenix, Arizona, 85008, United States

Location

LAC + USC Medical Center

Los Angeles, California, 90033, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

Henry Ford Health System

Detroit, Michigan, 48208, United States

Location

Washington University School of Medicine; Div. of Emergency Medicine

St Louis, Missouri, 63110, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (1)

• Lewis LM, Ferguson I, House SL, Aubuchon K, Schneider J, Johnson K, Matsuda K. Albuterol administration is commonly associated with increases in serum lactate in patients with asthma treated for acute exacerbation of asthma. Chest. 2014 Jan;145(1):53-59. doi: 10.1378/chest.13-0930.

  PMID: 23949578 DERIVED

MeSH Terms

Conditions

Asthma; Status Asthmaticus

Interventions

bedoradrine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Kazuko Matsuda, MD PhD MPH, Vice President, Clinical Development
• Organization: MediciNova, Inc.

matsuda@medicinova.com

858-373-1500

Study Officials

• Michael Kalafer, MD

  MediciNova

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 7, 2011
• Results First Posted: July 29, 2011

Record last verified: 2011-10

Locations

US (9)