A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment. (TRIPLE10)

Chiesi

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Beclometasone/Formoterol/Glycopyrrolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02040597

2013-002140-91 (EudraCT Number)

CCD-05993AA1-10

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers and
• Subjects with mild, moderate and severe renal impairment

Exclusion criteria

• pregnant or lactating women
• positive HIV and hepatitis serology
• history of drug abuse
• history of hypersensitivity to the products used in the trial
• smokers
• respiratory disease such as asthma and COPD
• clinically relevant concomitant disease that may introduce a risk for the subjects'safety
• presence of kidney stones
• dialysis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

CHF5993 pMDI

Experimental group

Description:

CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations

Treatment:

Drug: Beclometasone/Formoterol/Glycopyrrolate