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

NCT ID: NCT02040597

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CHF5993 pMDI

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

Group Type EXPERIMENTAL

Beclometasone/Formoterol/Glycopyrrolate

Intervention Type DRUG

Interventions

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Beclometasone/Formoterol/Glycopyrrolate

Intervention Type DRUG

Other Intervention Names

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CHF 5993 pMDI

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piotr Kuna, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University in Lodz

Kasia Jarus-Dziedzic, MD

Role: PRINCIPAL_INVESTIGATOR

Biovirtus

Locations

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Biovirtus Research Site

Nadarzyn, Mokra 7, Poland

Site Status

Medical University in Lodz

Lodz, Ul. Kopcińskiego 22, Poland

Site Status

Countries

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Poland

Related Links

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https://www.chiesi.com/clinic/CSR_Synopsis_CCD-05993AA1-10.pdf

CSR Synopsis available in the Chiesi Clinical Study Register

Other Identifiers

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2013-002140-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCD-05993AA1-10

Identifier Type: -

Identifier Source: org_study_id