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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002140-91 | EudraCT Number |
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The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF5993 pMDI | Experimental | CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclometasone/Formoterol/Glycopyrrolate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycopyrrolate area under the curve (AUC) | AUC until the last quantifiable concentration (AUCt) | over 72 h after single administration |
| Measure | Description | Time Frame |
|---|---|---|
| Glycopyrrolate other Pharmacokinetic parameters in plasma | AUC until 72 h post dose (AUC0-72h), AUC extrapolated to infinity (AUCinf), maximum plasma concentratio (Cmax), time to maximum plasma concentration (tmax), half-life, clearance | Over 72 h after single administration |
| B17MP and Formoterol pharmacokinetic parameters in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Kuna, MD | Medical University in Lodz | Principal Investigator |
| Kasia Jarus-Dziedzic, MD | Biovirtus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biovirtus Research Site | Nadarzyn | Mokra 7 | 05-830 | Poland | ||
| Medical University in Lodz |
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AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance |
| over 24 h after single administration |
| BDP pharmacokinetic parameters in plasma | AUCt, AUCinf, Cmax, tmax, half-life | over 24 h after single administration |
| Urine Glycopyrrolate excretion (Ae) | over 72 h after single administration |
| Urine formoterol excretion (Ae) | Over 24 h after single administration |
| Adverse events | This includes a period of 3 to 7 weeks (depending on duration of screening and follow-up periods), before and after the study drug administration | A period of 3 to 7 weeks (from screening visit to follow-up phone call) |
| Vital signs | systolic and diastolic blood pressure | over 24 h after single administration |
| Electrocardiogram (ECG) parameters | Heart rate (HR), time interval between ECG waves Q and T corrected for heart rate with Fridericia's formula (QTcF), time interval between the onset of the ECG wave P and the start of the QRS complex (PR), time interval between the beginning of Q wave and the termination of the S wave (QRS) | over 24 h after single administration |
| Lodz |
| Ul. Kopcińskiego 22 |
| 90-153 |
| Poland |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
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