Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

Exclusion Criteria

• •1. Female subjects: pregnant or lactating women
• •2. Past or current history of asthma
• •3. History of clinically significant hypotensive episodes
• •4. History or symptoms of significant cardiovascular disease
• •5. History or symptoms of significant neurological disease
• •6. Unstable concurrent disease
• •7. An abnormal and clinically significant 12-lead ECG
• •8. Clinically relevant abnormal laboratory values
• •9. Use of oral or systemic corticosteroids oral and/or nebulised Beta2 agonists and/or antibiotics within 6 weeks preceding the screening visit
• •10. Moderate or severe hepatic impairment (Child-Pugh B or C)
• •11. Intolerance/hypersensitivity or any contraindication to treatment with roflumilast, tiotropium bromide or salbutamol or any of the excipients contained in the formulations used in the study
• •12. Chronic use of any other medication for treatment of lung disease like xanthines, antileukotrienes, systemic and inhaled corticosteroids, long acting beta2- agonists, roflumilast (other than the study drug) and cromoglycates
• •13. Long term (at least 12 hours daily) use of oxygen therapy for chronic hypoxemia.
• •14. Having received an investigational medicinal drug within 30 days prior to study entry
• •15. Blood draws of 250 mL or more within 45 days prior to enrolment into the study.
• •16. Known respiratory disorders other than COPD.
• •17. History of alcohol dependency, or substance abuse
• •18. Inability to comply with the study Protocol for any other reason.