COPD
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve of B17MP, formoterol and glycopyrrolate | Over 24 and 48h after single administration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | over a period of 6 to 11 weeks | from the signature of the informed consent until the follow-up phone call |
| Lung function | 30 min after single administration | FEV1 |
| plasma cortisol | over 24 h after single administration | cortisol AUC0-24h, Cmin and tmin |
| Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma | over 24 or 48h after single administration | 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 |
| potassium plasma profile | over 24 h after single administration | potassium AUC0-24h, tmin and Cmin |
| Vital signs | over 24 h after single administration | systolic and diastolic blood pressure |
| ECG parameters | over 24 h after single administration | extracted from holter recording HR, QTcF, PR and QRS |
| cortisol urinary excretion | over 24 h after single administration | cortisol excretion corrected and not corrected for creatinine |
Countries
Poland
Outcome results
None listed