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Sponsor's R&D strategy adjusted.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Drug1 dose 1+Drug 3 |
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| Treatment group B | Experimental | Drug1 dose 2+Drug 2+Drug 3 |
|
| Treatment group C | Experimental | Drug1 dose 3+Drug 2+Drug 3 |
|
| Treatment group D | Other | Drug 2+Drug 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRG2005 inhalation | Drug | Drug 1: dose 1; dose 2; dose 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in morning pre-dose trough FEV1 at week 12 | Up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in morning pre-dose trough FEV1 at each time point | up to week 48 | |
| Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point | up to week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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This is a randomized, double blind, double dummy, active-controlled, parallel-group study.
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| Placebo to match HRG2005 inhalation | Drug | Drug 2 |
|
| Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation | Drug | Drug 3 |
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| Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation | Drug | Drug 4 |
|
| Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1 | up to week 48 |
| Peak change from baseline in FEV1 at week 12 | 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 | Up to week 12 |
| Rate of moderate or severe COPD exacerbations over 48 Weeks | up to week 48 |
| Rate of severe COPD exacerbations over 48 Weeks | up to week 48 |
| Change from baseline in CAT (COPD Assessment test) total score at each time point | up to week 48 |
| Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point | up to week 48 |
| Incidence and severity of adverse events | Up to week 50 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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