Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)

Study Identifier:
CCD-5993AA1-14
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Rhinosinusitis
Study Drug
  • Drug: CHF 5993 100/6/12.5 µg
  • Drug: 160 µg budesonide + 4.5 µg formoterol fumarate
Date
Dec 2016 - May 2020
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Healthy Volunteers
No

Protocol Summary

The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.

Study Locations

Location
Status
Location
Chiesi clinical Trial Site 156031
Beijing, Beijing, China, 100000
Status
N/A
Location
Chiesi Clinical Trial Site 156026
Beijing, Beijing, China, 100020
Status
N/A
Location
Chiesi clinical Trial Site 156017
Beijing, Beijing, China, 100029
Status
N/A
Location
Chiesi Clinical Trial Site 156012
Beijing, Beijing, China, 100144
Status
N/A
Location
Chiesi Clinical Trial Site 156045
Chongqing, Chongqing, China, 400000
Status
N/A
Location
Chiesi Clinical Trial Site 156002
Fuzhou, Fujian, China, 350005
Status
N/A