Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase I Randomized, Double-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously to Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Verified date | May 2015 |
Source | MediciNova |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Male or female 40-65 years of age, inclusive; 2. History of physician-diagnosed COPD treated for = 3 months ; 3. FEV1 = 30% < 80% and FEV1/FVC ratio < 0.7 at screening; 4. An increase in FEV1 of at least 12%, over the pre-albuterol FEV1 within 30 minutes after inhalation of albuterol; 5. 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); 6. Negative urine drug screen for cocaine, PCP, methamphetamine; 7. ECG with no evidence of ischemic heart disease or dysrhythmias and otherwise normal or with findings considered not clinically significant at screening; 8. QTcB and QTcF < 450 msec; 9. No clinical evidence of active ischemic heart disease as determined by the Investigator; and 10. Legally effective written informed consent obtained prior to starting any study procedures. Exclusion Criteria: 1. Beta agonist and/or anticholinergic via inhaler or intravenously = 6 hours of screening; 2. Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists = 24 hours prior to screening; 3. A diagnosis of clinically significant myocardial or valvular disease; including cardiomyopathy, congestive heart failure, or pulmonary edema; 4. Acute exacerbation of COPD requiring emergency treatment = 30 days of screening or hospitalization = 90 days of screening; 5. Antibiotic therapy for respiratory infection = 30 days of screening; 6. Presence of active respiratory disease such as pneumonia, or acute bronchitis; 7. History or presence of tachyarrhythmias, with the exception of sinus tachycardia; 8. Hypokalemia defined as a potassium level = 3.0 mmol/L at screening; 9. Significant renal, hepatic, endocrine, metabolic, neurologic or other systemic disease; 10. Uncontrolled hypertension defined as a blood pressure = 170/100 mm Hg at screening; 11. Pregnant or lactating females; 12. Participation in another clinical study with an investigational drug within 30 days of screening; 13. A known allergy to excipients of the MN-221 drug product; 14. A known allergy to other beta agonists; 15. Previous exposure to MN-221; or 16. Use of beta blockers, MAO inhibitors, or tricyclic antidepressants = 2 weeks prior to screening. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | SNBL CLinical Pharmacology Center | Baltimore | Maryland |
United States | California Research Medical Group, INC | Fullerton | California |
United States | Gulf Coast Research, LLC | Lafayette | Louisiana |
United States | Vince and Associates Clinical Research | Overland Park | Kansas |
United States | Dedicated Phase I | Phoenix | Arizona |
United States | Vita Research Solutions & Medical Center, Inc. | Tamarac | Florida |
United States | Florida Pulmonary Research Institue, LLC | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
MediciNova |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments. | Hour 0 (treatment) through Hour 24 (follow-up) | Yes | |
Secondary | Pharmacokinetic parameters of MN-221. | Pre-dose to Hour 24 post-dose | No | |
Secondary | Forced expiratory volume in one second (FEV1). | Pre-dose to Hour 24 post-dose | No |
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