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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
JKN2403 Tablets once daily orally, for 24 weeks
Placebo
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGThe annualized incidence rate of moderate to severe AECOPD
Time frame: at 24 months
The duration from the first administration to the first occurrence of moderate to severe AECOPD
Time frame: at 24 months
trough (pre-bronchodilator) FEV1
Time frame: at 4, 8, 12 ,16, 20 and 24 weeks
quality of life(SGRQ score)
Time frame: at 4, 8,12, 16, 20 and 24 weeks
quality of life (CAT score)
Time frame: at 4, 8,12, 16, 20 and 24 months
The annualized incidence rate of CID
Time frame: at 24 weeks
The duration from the first administration to the first occurrence of CID
Time frame: at 24 weeks
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