COPD: Study 1
Research Study for Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this research study is to determine how safe and effective a combined investigational inhaled medication is when taken for a long period of time compared to taking the individual components of that drug in the treatment of patients with chronic obstructive pulmonary disease (COPD).
This study is for males and females at least 40 years of age who have a diagnosis of COPD and meet spirometry criteria.
Inclusion/Exclusion Criteria:
- Subjects must have greater than a 10 pack year smoking history
- Current and former smokers will be accepted
- Known significant disease other than COPD will not be permitted
- Subjects cannot be or become pregnant during the study
- Regular use of daytime oxygen therapy for greater than 1 hour a day will not be permitted
- Pulmonary rehabilitation in the 6 weeks prior to visit 1 or current participation will not be permitted
The total duration of participation, including follow up will be approximately 55 weeks. There will be a total of 12 clinic visits conducted on an outpatient basis. Visits will consist of spirometry, physical examinations, vital signs, laboratory examinations, EKGs and the completion of questionnaires. All study related care including study medication will be provided to participants at no cost. Subjects may be reimbursed for their time and certain travel expenses.
