Clinical trial NCT01013142 (phase 1, status: completed)
Conditions: chronic obstructive pulmonary disease
ICD codes: J44.9, J44.1, J44.0
Drugs: mn-221 (dose group 1), mn-221 (dose group 2), mn-221 (dose group 3)
SMILES: CN(C)C(=O)COC1=CC=C2CC[C@@H](CC2=C1)NC[C@H](O)C1=CC=C(O)C(CCO)=C1, CN(C)C(=O)COC1=CC=C2CC[C@@H](CC2=C1)NC[C@H](O)C1=CC=C(O)C(CCO)=C1, CN(C)C(=O)COC1=CC=C2CC[C@@H](CC2=C1)NC[C@H](O)C1=CC=C(O)C(CCO)=C1
Eligibility criteria:

        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.