Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma

NCT00679263 | Completed Phase 2 Results

• 1 other identifier: MN-221-CL-005
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of MN-221 at two different dosing rates administered through a continuous infusion in subjects diagnosed with moderate to severe asthma.

Conditions

Asthma

Keywords

asthma; randomized; placebo controlled; dose escalation; safety; efficacy; single blind; MN-221

Outcome Measures

Primary Outcomes (1)

• Number of Patients Reported to Have Adverse Events

  Day 1 to Day 2

Secondary Outcomes (1)

• FEV1 Percent Predicted Changes From Base Line

  Day 1 to Day 2

Study Arms (2)

MN-221

EXPERIMENTAL

Drug: MN-221

PLACEBO

PLACEBO COMPARATOR

Placebo intravenous infusion with dosing volume equivalent to active treatment.

Drug: Placebo

Interventions

MN-221 DRUG

Initial dose: 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg)

MN-221

Placebo DRUG

Placebo intravenous infusion with dosing volume equivalent to active treatment.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects;
• Must sign an informed consent;
• Diagnosis of asthma as defined by the American Thoracic Society for at least 3 months;
• Must not be receiving inhaled corticosteroids for control within 1 month of study;
• Must have an increase in FEV1 of at least 12% and 200 cc over the pre-albuterol FEV1 within 30 minutes after inhalation of up to 4 puffs of albuterol via a metered dose inhaler;
• Non-smoker for at least 6 months and in good health;
• Female subjects must have a negative pregnancy test;
• Male and female subjects of child-bearing potential (not surgically sterile or post menopausal) must be abstinent or agree to use contraceptive regimens throughout the study;
• Subjects receiving allergy desensitization therapy can participate as long as they have been on a stable maintenance dose for ≥ 6 months;
• Subject must be willing and able not to use inhaled bronchodilators for 6 hours before and until 24 hours after each study drug administration at all study visits; and
• Subject must demonstrate mental and physical ability and willingness to follow all study-specific instructions pertaining to the scheduling of study visits and assessments.

You may not qualify if:

• Have significant cardiopulmonary, renal, hepatic, endocrine, metabolic, neurological or other systemic disease;
• Received emergency treatment for asthma within 1 month, or hospitalized for asthma within 3 months;
• Had an upper or lower respiratory tract infection within 3 weeks, or sinus infection within 7 days;
• Have participated in a clinical study with an investigational drug, other than an MN-221 study, within 30 days;
• Have history or evidence of drug or alcohol abuse within 2 years of study entry;
• Female subjects who are pregnant or lactating;
• Taking any of the following excluded asthma/allergy medications within the time periods indicated prior to the first study visit:
• Oral, inhaled, or parenteral corticosteroids for 1 month prior to the first study visit.
• Anti-IgE medication for 3 months prior to the first study visit.
• Theophylline, long-acting bronchodilators, and anti-cholinergics for 2 weeks prior to the first study visit.
• Taking leukotriene modifiers and not on a stable daily dosage for 4 weeks prior to the first study visit.
• Taking antihistamines, nasal corticosteroids, or decongestants and not on a stable dose for 3 days prior to any dosing day.
• Have a known allergy to MN-221 or any of the other components of the study drug (i.e. lactose);
• Have a history of frequent episodes of orthostatic hypotension or any predisposition for orthostatic hypotension;
• Taking any drugs or substances known to be strong inhibitors of cytochrome P450 enzymes within 10 days of study entry, or the expected need to use such drugs ten days prior to the first study visit until after completion of the study;

Sponsors & Collaborators

• MediciNova: lead

Study Sites (4)

PRA International

Lenexa, Kansas, 66219, United States

Location

Northeast Medical Research Associates

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research of the Ozarks

Rolla, Missouri, 65401, United States

Location

Greenville Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Related Publications (1)

• Matsuda K, Makhay M, Johnson K, Iwaki Y. Evaluation of bedoradrine sulfate (MN-221), a novel, highly selective beta2-adrenergic receptor agonist for the treatment of asthma via intravenous infusion. J Asthma. 2012 Dec;49(10):1071-8. doi: 10.3109/02770903.2012.729631. Epub 2012 Oct 25.

  PMID: 23094708 DERIVED

MeSH Terms

Conditions

Asthma

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, Vice President Clinical Development
• Organization: Medicinova Inc

matsuda@medicinova.com

858-373-1500

Study Officials

• Michael Kalafer

  MediciNova, Inc.

  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 14, 2008
• First Posted: May 16, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 19, 2011
• Results First Posted: December 15, 2011

Record last verified: 2011-11

Locations

US (4)