Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients

Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer

The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.

Inclusion Criteria:

• COPD patients
• smokers or ex-smokers
• post-bronchodilator FEV1 between 30 and 60% of predicted value

Exclusion Criteria:

• Positive serology to HIV and hepatitis
• Known respiratory disorder other than COPD
• Recent COPD exacerbations or hospitalization for COPD
• Treatment with non-permitted concomitant medication
• clinically relevant concomitant disease
• clinically relevant abnormal laboratory or ECG parameters