Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria

• Inclusion Criteria:
• - Signed written informed consent
• - 40 - 80 years of age
• - Fluency in written and spoken English
• - Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
• - Current/former smokers with at least a 10 pack-year history of cigarette smoking
• - A measured post-salbutamol FEV1/FVC ratio of < or = 0.70
• - A measured post-salbutamol FEV1 > or = 40 and < or = 80% of
• predicted normal values
• - Demonstrated reversibility to a short acting beta agonist by either >12% and >150 ml improvement in baseline FEV1, 30 minutes following administration of
• 4 puffs of salbutamol MDI or an absolute improvement of >200 ml in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI.
• - Competent at using the inhalation device
• Exclusion Criteria:
• - Women who are pregnant or lactating
• - Primary diagnosis of asthma
• - Alpha-1 antitrypsin deficiency as the cause of COPD
• - Active pulmonary diseases
• - Prior lung volume reduction surgery
• - Abnormal chest X-ray (or CT scan) not due to the presence of COPD
• - Hospitalized due to poorly controlled COPD within 24 weeks of Screening
• - Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
• - Clinically significant medical conditions
• - Lower respiratory tract infection requiring antibiotics in past 6 weeks
• - Clinically significant abnormal ECG
• - Clinically significant uncontrolled hypertension
• - Positive Hepatitis B surface antigen or Hepatitis C antibody
• - Cancer that has not been in complete remission for at least 5 years
• - History of hypersensitivity to any beta2-agonists or any study drug component
• - History of severe milk protein allergy
• - Known or suspected history of alcohol or drug abuse
• - Medically unable to withhold short acting bronchodilators for 8-hours
• - Use of the medications below in specified time interval prior to Screening: 12-weeks: depot corticosteroids, intra-articular corticosteroids; 4 weeks: ICS >1000 μg/day of fluticasone propionate or equivalent, non-potassium sparing diuretics, P-glycoprotein inhibitors, CYP3A4 inhibitors; 1 week: tiotropium; 48 hours: oral beta agonists, long acting beta agonists, theophylline, zariflukast, montelukast, zileuton; 8 hours: ipratropium or ipratropium/salbutamol combination product, inhaled short acting beta agonists, xanthine containing foods
• - Use of the following medications is prohibited: tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates,hydantoins, and carbamazepine and phenothiazines
• - Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
• - Diagnosis of sleep apnea that is uncontrolled
• - Participation in acute phase of pulmonary rehabilitation in prior 4 weeks or will enter acute phase of pulmonary rehabilitation program during study
• - Unable to comply with study procedures
• - Affiliated with Investigator site
• - Questionable validity of consent
• - A positive drug of abuse test at Screening
• lives prior to Screening, whichever is longer