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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003770-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF5993 pMDI + Spacer | Experimental | CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer |
|
| CHF5993 pMDI | Active Comparator | CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only |
|
| Placebo pMDI | Placebo Comparator | Placebo pMDI x 4 inhalations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclometasone/formoterol/glycopyrrolate | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Over 24 and 48h after single administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | over 24 or 48h after single administration |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Kuna, MD | Medical University Lodz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University in Lodz | Lodz | Ul. Kopcińskiego 22 | 90-153 | Poland |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo |
| Drug |
|
from the signature of the informed consent until the follow-up phone call |
| over a period of 6 to 11 weeks |
| Lung function | FEV1 | 30 min after single administration |
| plasma cortisol | cortisol AUC0-24h, Cmin and tmin | over 24 h after single administration |
| cortisol urinary excretion | cortisol excretion corrected and not corrected for creatinine | over 24 h after single administration |
| potassium plasma profile | potassium AUC0-24h, tmin and Cmin | over 24 h after single administration |
| Vital signs | systolic and diastolic blood pressure | over 24 h after single administration |
| ECG parameters | extracted from holter recording HR, QTcF, PR and QRS | over 24 h after single administration |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |