The purpose of this study is to evaluate the dose-response relationship of different doses of CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further development in the target patient population.
This is a phase II, randomized, double-blind, double-dummy, placebo and active controlled multinational, multicenter, dose ranging, 6-arm parallel-group study to identify the optimal dose of CHF6001, PDE4 inhibitor under development, with respect to lung functions and symptoms. After a 2-wk run-in period under formoterol (Oxis Turbohaler®) and rescue salbutamol prn, patients will be randomized to one of the 6 treatment groups. After the randomization, patients will be assessed after 3, 6, 12, 18 and 24 weeks of treatment at clinic/hospital. A follow-up visit will be performed 12 days after the last visit. During the study, patients will report daily symptoms with the EXACT-PRO/E-RS questionnaire, rescue/background medication use and compliance with the study medications. AEs, SAEs and COPD exacerbations will be monitored throughout the study. At randomization and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurement, 12-lead ECG. Symptoms and Health status will be assessed through validated questionnaires. Routine lab analysis and blood biomarkers will be done.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,130
Dose response: Test one of 4 different doses of CHF6001
active control
placebo control
Change from baseline in predose morning FEV1 at 12 weeks
overall effect of CHF6001 on change from baseline in predose morning FEV1
Time frame: week 12
Change from baseline in predose morning FEV1 at other timepoints
Change from Baseline
Time frame: weeks 3, 6, 18, 24
Change from baseline in pre-dose morning IC
Change from Baseline for other lung function parameters
Time frame: weeks 3, 6, 12, 18, 24
Change from baseline in pre-dose morning FVC
Change from Baseline for other lung function parameters
Time frame: weeks 3, 6, 12, 18, 24
Change from baseline in TDI focal score
Change of TDI score
Time frame: weeks 3, 6, 12, 18, 24
Change from baseline in SGRQ score
Change of SGRQ score
Time frame: weeks 3, 6, 12, 18, 24
Change from baseline in E-RS score
Change of E-RSI score
Time frame: weeks 3, 6, 12, 18, 24
COPD exacerbation rate over 24 weeks of treatment
exacerbation rate
Time frame: 24 weeks
Time to first COPD exacerbation
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Time to first COPD exacerbation
Time frame: 24 weeks