To evaluate the efficacy and safety of TQC3721 inhalation powder in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
TQC3721 inhalation powder is target inhibitor.
Placebo for TQC3721 inhalation powder.
Change of the maximum value of Forced Expiratory Volume in the first second (FEV1)
Change of the maximum value of FEV1 was determined from baseline to four weeks after treatment.
Time frame: From baseline to four weeks after treatment
Number of subjects of changes in the peak, trough values of FEV1 and average FEV1 AUC
Number of subjects of changes in the peak, trough values of FEV1 and average FEV1 Area under the curve (AUC) within 3 hours and 12 hours after morning administration on 1 day, 2 weeks and 4 weeks of treatment compared with the baseline.
Time frame: From baseline to four weeks after treatment
Valley concentration
Evaluating valley concentration of TQC3721 (in selected patients only).
Time frame: From baseline to four weeks after treatment
Adverse Events (AE)
The subjets with the number, frequency, incidence, and severity of adverse events, serious adverse events, and adverse events associated with investigational drugs (including investigational drugs and control drugs), as well as abnormal laboratory indicators were evaluated.
Time frame: From baseline to safety visit(about 5 weeks after first dosing)
Frequency of rescue medication used during the study
Frequency of rescue medication used during the study compared to placebo group
Time frame: From baseline to four weeks after administration
Changes in Chronic obstructive pulmonary disease Assessment Test (CAT)
Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline.The CAT questionnaire is mainly used to assess the impact of COPD on patients' health and daily quality of life.There are 8 questions in the CAT, and each question is scored 0-5 points, with the higher score meaning the more severe symptoms.
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chognqing, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Guigang People's Hospital
Guigang, Guangxi, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
The People's Hospital of Liuyang
Changsha, Hunan, China
Xiangtan County People's Hospital
Xiangtan, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
...and 19 more locations
Time frame: From baseline to four weeks after treatment
Changes in St. George's Respiratory Questionnaire (SGRQ)
Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline. The SGRQ is a standardized self-assessment tool used to evaluate the quality of life of patients with chronic respiratory diseases. It quantifies the degree of impairment in patients' symptoms, activity capacity and social psychological adaptation, and comprehensively reflects the impact of the disease on patients' daily lives.
Time frame: From baseline to four weeks after treatment
Peak concentration
Evaluating peak concentration of TQC3721 (in selected patients only)
Time frame: From baseline to four weeks after treatment
Area under the concentration-time curve from 0 to last observation (AUC 0-t) of TQC3721
Evaluating Area under the concentration-time curve from 0 to last observation (AUC 0-t) of TQC3721. (in selected patients only)
Time frame: From baseline to four weeks after treatment
Apparent volume of distribution (Vd/F)
Evaluating Vd/F of TQC3721. (in selected patients only)
Time frame: From baseline to four weeks after treatment
Apparent clearance (CL/F)
Evaluating Apparent clearance (CL/F) of TQC3721. (in selected patients only)
Time frame: From baseline to four weeks after treatment
Half-ife (t1/2)
Evaluating the time required for half of the drug to be eliminated from the plasma of TQC3721. (in selected patients only)
Time frame: From baseline to four weeks after treatment