Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

Study Identifier:
CCD-05993AA1-09
ClinicalTrials.gov Identifier:
NCT02189577
EudraCT Identifier:
2013-005268-25
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: CHF 5259
  • Drug: Placebo
Date
Jun 2014 - Feb 2015
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40 - 80 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD
  • Current smokers or ex-smokers
  • A post-bronchodilator FEV1 \< 60% of the predicted normal value and a post-bronchodilator FEV1/FVC \< 0.7
  • Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.
  • BDI score ≤ 10
  • Patients free of exacerbations for at least 1 month
Exclusion Criteria
  • Pregnant or lactating women
  • Diagnosis of asthma
  • Patients treated for exacerbations in the 4 weeks prior to screening visit
  • Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
  • Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
  • Known respiratory disorders other than COPD
  • Patients who have clinically significant cardiovascular condition
Healthy Volunteers
No

Protocol Summary

The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.

Study Locations

Location
Status
Location
Chiesi Clinical Trial Site 1017
Sevlievo, Bulgaria
Status
N/A
Location
Chiesi Clinical Trial Site 1010
Sofia, Bulgaria
Status
N/A
Location
Chiesi Clinical Trial Site 1011
Sofia, Bulgaria
Status
N/A
Location
Chiesi Clinical Trial Site 1014
Sofia, Bulgaria
Status
N/A
Location
Chiesi Clinical Trial Site 1015
Sofia, Bulgaria
Status
N/A
Location
Chiesi Clinical Trial Site 1016
Sofia, Bulgaria
Status
N/A
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