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Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551316
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):

Brief Summary:

In MediciNova's clinical development plan for MN-221, it was recognized that treatment of COPD exacerbations may necessitate more than one single i.v. infusion and that patients in this population may have more co-morbidities (and concomitant medications) than has been generally studied so far. Thus, the primary objective of this clinical study is to determine the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to placebo with repeated administration over several days in moderate to severe COPD patients who may also have co-morbidities and concomitant medications (CM) common in this population. Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).

This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human clinical trial information.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: MN-221 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ib Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Repeated Administration, Intravenous MN-221 in Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: MN-221
If the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused.
Drug: MN-221
This drug is intravenously infused and delivers 1200 mcg to the patient in 1 hour duration. This dose is repeated over 4 days (Day 1 1200 mcg once; Day 2 1200 mcg twice; Day 3 1200 mcg twice; Day 4 1200 mcg once).
Other Name: Bedoradrine Sulfate

Experimental: PLACEBO
If the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused.
Drug: Placebo
This intervention consists of a placebo intravenous infusion, one that contains no active medication. During the double-blind procedure, patients will be infused with placebo intravenously one time on Day 1, twice on Days 2 and 3, and one time on Day 4.

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Treatment Days 1- 5 ]
    The recording of AEs will start after the subject has signed the consent form and will end at the Hour 24 phone interview. Investigator(s) will monitor each subject closely for AEs and the Investigator will record all observed or volunteered AEs.

Secondary Outcome Measures :
  1. MN-221 and primary metabolite levels will be analyzed by liquid chromatography/mass spectrometry/mass spectrometry. [ Time Frame: Treatment Days 1-5 ]
    Blood samples will be analyzed for MN-221 and primary metabolite levels by liquid chromatography/mass spectrometry (LC/MS/MS.

  2. Evaluation of respiratory parameters (FEV1, peak flow, accessory muscle use, respiratory rate) [ Time Frame: Screening, Treatment Days 1,3,5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female 40-75 years of age, inclusive;
  • History of physician-diagnosed (e.g., by clinical history, >15-pack year history of smoking, physical examination, and spirometry) COPD treated for ≥ 3 months prior to Visit 1 Pre-Screening;
  • FEV1 ≥ 30% and < 80% predicted and FEV1/FVC ratio < 0.7 at Visit 1 Pre-Screening and Visit 2 Screening;
  • Negative urine pregnancy test for all females unless the subject is post-menopausal (≥ 24 months of spontaneous amenorrhea) or surgically sterile (hysterectomy, bilateral ovariectomy or bilateral tubal ligation);
  • Negative urine drug screen for cocaine, phencyclidine (PCP), methamphetamine;
  • Negative alcohol breath test;
  • Electrocardiogram (ECG) without serious abnormality and with QTcB and QTcF < 460 milliseconds (msec);
  • Ability to wash-out of concomitant LABA and Theophylline, if ongoing, for 7-8 days (i.e., Visit 2 Screening through 5-Day Treatment Period).
  • Legally effective written informed consent obtained prior to starting any study procedures.
  • Subject willing and able to comply with the protocol and procedures, as judged by Investigator.

Exclusion Criteria:

  • Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 48 hours prior to treatment start (Day 1);
  • Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 60 days of Visit 2 Screening;
  • Antibiotic therapy for respiratory infection ≤ 15 days of Visit 2 Screening;
  • Presence of active respiratory disease such as pneumonia and acute exacerbation of chronic bronchitis;
  • Hypokalemia defined as a potassium level <3.0 mmol/L at Visit 2 Screening. note: Subjects <3.0 mmol/L may be re-screened at Visit 2 Screening after receiving potassium replacement therapy;
  • Significant clinical laboratory abnormality that, in the opinion of the Investigator, may put the subject at risk;
  • Significant renal, hepatic, endocrine, neurologic or other systemic disease that, in the opinion of the Investigator, may put the subject at undue risk;
  • Uncontrolled hypertension (defined as a blood pressure ≥ 170/100 mm Hg at Visit 1 Pre-Screening) and/or uncontrolled angina, uncontrolled diabetes, uncontrolled congestive heart failure (CHF), uncontrolled serious arrhythmia;
  • Myocardial infarction within 6 months of treatment start;
  • Pregnant or lactating females;
  • Participation in another clinical study with an investigational drug within 30 days of Visit 1 Pre-Screening;
  • Patients with home oxygen requirements.
  • A known allergy to excipients of the MN-221 drug product;
  • A known allergy to other beta agonists;
  • Currently on medication/s that are recognized to have risk of Torsades de Pointes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01551316

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United States, Texas
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Responsible Party: MediciNova Identifier: NCT01551316    
Other Study ID Numbers: MN-221-CL-012
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012
Keywords provided by MediciNova:
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases