The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.
A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Chiesi Clinical Trial Site 1017
Change from baseline in pre-dose morning FEV1 on Day 28
Time frame: Day 28
Change from baseline to day 28 in area under the curve for forced expiratory volume in 1 second measured at 11 timepoints between 0 to 12 hours postdose (FEV1 AUC0-12h)
Time frame: Day 28
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Sevlievo, Bulgaria
Chiesi Clinical Trial Site 1010
Sofia, Bulgaria
Chiesi Clinical Trial Site 1011
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Chiesi Clinical Trial Site 1014
Sofia, Bulgaria
Chiesi Clinical Trial Site 1015
Sofia, Bulgaria
Chiesi Clinical Trial Site 1016
Sofia, Bulgaria
Chiesi Clinical Trial Site 1012
Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 1013
Troyan Municipality, Bulgaria
Chiesi Clinical Trial Site 2024
Berlin, Germany
Chiesi Clinical Trial Site 2028
Berlin, Germany
...and 19 more locations