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

Study Identifier:
CCD-05993AA1-10
ClinicalTrials.gov Identifier:
NCT02040597
EudraCT Identifier:
2013-002140-91
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
Download document(s)

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: Beclometasone/Formoterol/Glycopyrrolate
Date
Jan 2014 - Apr 2015
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
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
Healthy Volunteers
Yes

Protocol Summary

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.

Study Locations

Location
Status
Location
Biovirtus Research Site
Nadarzyn, Mokra 7, Poland, 05-830
Status
N/A
Location
Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, Poland, 90-153
Status
N/A