Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients

Study Identifier:
CCD-05993AA1-04
ClinicalTrials.gov Identifier:
NCT02119234
EudraCT Identifier:
2013-003770-27
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
  • Drug: Placebo
Date
Mar 2014 - Feb 2015
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 45 - 70 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • COPD patients
  • smokers or ex-smokers
  • post-bronchodilator FEV1 between 30 and 60% of predicted value
Exclusion Criteria
  • Positive serology to HIV and hepatitis
  • Known respiratory disorder other than COPD
  • Recent COPD exacerbations or hospitalization for COPD
  • Treatment with non-permitted concomitant medication
  • clinically relevant concomitant disease
  • clinically relevant abnormal laboratory or ECG parameters
Healthy Volunteers
No

Protocol Summary

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.

Study Locations

Location
Status
Location
Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, Poland, 90-153
Status
N/A