This is a randomized, double blind, double dummy, active-controlled, parallel-group study to assess the efficacy and Safety of HRG2005 inhalation in patients with moderate to severe chronic obstructive pulmonary disease. Approximately 200 patients with moderate to severe COPD will be randomized into the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
Drug 1: dose 1; dose 2; dose 3
Drug 2
Peking University Third Hospital
Beijing, Beijing Municipality, China
Change from baseline in morning pre-dose trough FEV1 at week 12
Time frame: Up to week 12
Change from baseline in morning pre-dose trough FEV1 at each time point
Time frame: up to week 48
Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point
Time frame: up to week 48
Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
Time frame: up to week 48
Peak change from baseline in FEV1 at week 12
Time frame: Up to week 12
FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12
Time frame: Up to week 12
Rate of moderate or severe COPD exacerbations over 48 Weeks
Time frame: up to week 48
Rate of severe COPD exacerbations over 48 Weeks
Time frame: up to week 48
Change from baseline in CAT (COPD Assessment test) total score at each time point
Time frame: up to week 48
Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point
Time frame: up to week 48
Incidence and severity of adverse events
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Drug 4
Time frame: Up to week 50