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| ID | Type | Description | Link |
|---|---|---|---|
| JKN2403-IIa | Other Grant/Funding Number | Joincare Pharmaceutical Group Industry Co., Ltd |
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The goal of this clinical trial is to learn if drug JKN2403 works to treat moderate-to-severe COPD in adults. It will also learn about the safety and pharmacokinetic characteristics of drug JKN2403. The main questions it aims to answer are:
Does drug JKN2403 reduce the incidence of AECOPD or improve the quality of life or alleviate symptoms related to COPD?
Researchers will compare drug JKN2403 to a placebo (a look-alike substance that contains no drug) to see if drug JKN2403 works to treat moderate-to-severe COPD.
Participants will:
Take drug JKN2403 or a placebo every day for 24 weeks Visit the clinic once every four weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose1 of JKN2403 Tablets, once daily orally | Experimental | dose1 of JKN2403 Tablets once daily orally, for 24 weeks |
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| dose2 of JKN2403 Tablets once daily orally | Experimental | dose2 of JKN2403 Tablets once daily orally, for 24 weeks |
|
| dose3 of JKN2403 Tablets once daily | Experimental | dose3 of JKN2403 Tablets once daily orally, for 24 weeks |
|
| Placebo once daily | Placebo Comparator | Placebo once daily orally, for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JKN2403 Tablets | Drug | JKN2403 Tablets once daily orally, for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The annualized incidence rate of moderate to severe AECOPD | at 24 months | |
| The duration from the first administration to the first occurrence of moderate to severe AECOPD | at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| trough (pre-bronchodilator) FEV1 | at 4, 8, 12 ,16, 20 and 24 weeks | |
| quality of life(SGRQ score) | at 4, 8,12, 16, 20 and 24 weeks | |
| quality of life (CAT score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijie Guan Professor | Contact | 020-81566265 | battery203@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo | Drug | Placebo |
|
| at 4, 8,12, 16, 20 and 24 months |
| The annualized incidence rate of CID | at 24 weeks |
| The duration from the first administration to the first occurrence of CID | at 24 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |