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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, Poland
Area under the curve of B17MP, formoterol and glycopyrrolate
AUCt (up to the last quantifiable concentration) and Cmax (maximum concentration) from plasma concentrations vs time profiles. over 24h for formoterol and B17MP, over 48h for glycopyrrolate
Time frame: Over 24 and 48h after single administration
Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma
B17MP AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Formoterol AUC0-30min, AUC0-24h, AUCinf, tmax, half-life Glycopyrrolate AUC0-30min, AUC0-48h, AUCinf, tmax, half-life
Time frame: over 24 or 48h after single administration
Adverse events
from the signature of the informed consent until the follow-up phone call
Time frame: over a period of 6 to 11 weeks
Lung function
FEV1
Time frame: 30 min after single administration
plasma cortisol
cortisol AUC0-24h, Cmin and tmin
Time frame: over 24 h after single administration
cortisol urinary excretion
cortisol excretion corrected and not corrected for creatinine
Time frame: over 24 h after single administration
potassium plasma profile
potassium AUC0-24h, tmin and Cmin
Time frame: over 24 h after single administration
Vital signs
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systolic and diastolic blood pressure
Time frame: over 24 h after single administration
ECG parameters
extracted from holter recording HR, QTcF, PR and QRS
Time frame: over 24 h after single administration