COPD: Study 1
COPD Study: PT009001-00
The purpose of this research study is to assess the safety and effectiveness of a twice daily investigational medication in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
- Males and females ages 40-80 years old
- Have a COPD diagnosis
- Current or former smokers will be accepted
- Subjects requiring oxygen more than 12 hours a day
- Subjects who have a primary diagnosis of asthma
- Women who are pregnant or lactating
- Subjects who have had cancer that has not been in complete remission for at least 5 years (squamous cell and basal cell carcinoma that has been removed for cure will be acceptable)
Additional criteria will be reviewed with the subject.
Volunteers will be asked to come to the clinic up to 14 visits. Visits will be conducted on an outpatient basis. Visits will consist of spirometry, physical examinations, vital signs, laboratory examinations, EKGs, and completion of questionnaires. All study related medical care including study medication will be provided to qualified participants at no cost. Qualified participants will be reimbursed for their time and certain travel expenses.