The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function,
reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety
outcomes in the target subject population.
This is a phase III, multinational, multicenter, randomized, double-blind active controlled
2-arm parallel group study to compare efficacy, safety, and tolerability of CHF 5993 pMDI
with CHF 1535 pMDI with respect to lung function, incidence of moderate and severe COPD
exacerbations, and other clinical efficacy and safety outcomes.
After screening, eligible subjects will enter 2-week run-in period using their regular COPD
maintenance therapies after which they will be randomized to one of 2 study treatment groups.
Following randomization, subjects will be assessed after 4 weeks then at 6-week intervals
thereafter for a period of 52 weeks. A follow-up safety phone call will be performed a week
after the last clinic visit. A subset of subjects consenting to participate in the
pharmacokinetic substudy will undergo additional assessments (totaling 3 visits) during the
scheduled study visits.
During the study, daily symptoms, rescue medication use and compliance with the study drug
will be recorded via a subject electronic diary. Subject concomitant medications, adverse
events, and healthcare resource utilization will be assessed and recorded throughout the
study. At intermittent study visits, subjects will undergo vital signs examinations including
weight, spirometry measurements, and 12-lead ECG. Symptoms and COPD health status will be
assessed through disease specific questionnaires. Routine hematology, blood chemistry, and
serum pregnancy testing will be performed before enrollment and at end of study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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