Summary:
A Randomized, double-blind, parallel-group, Multi-Center, placebo-controlled study to evaluate the long term efficacy and safety of XXXXX when administered via the Novel Dry Powder Inhaler. Once daily dosing will occur in the morning(with the exception of the first treatment visit)
Qualified Participants Must:
• Outpatient
Informed consent: Subjects must give their signed and dated written informend consent to participate.
Gender: Male or Female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in the accordance with local practice in relation to adequate contraception
Age: >40 and <80 years of age at screening (visit 1)
Tabacco use: Subject with a current or prior history of >10 pack-years of cigarette smoking at screening (visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 month prior visit 1