This is a phase II clinical trial to evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
TQC3721 suspension for inhalation is a dual inhibitor targeting PDE3/4.
Placebo without active substance.
Salbutamol is short-acting β2 receptor agonists.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Wuhan Sixth Hospital
Wuhan, Hubei, China
The peak of Forced Expiratory Volume in the 1st second (FEV1) (4 weeks)
Change of the maximum value of FEV1 from baseline to four weeks after treatment
Time frame: From baseline to four weeks after treatment.
Morning trough FEV1
The FEV1 before administration
Time frame: From baseline to four weeks after treatment.
Average FEV1 (4 weeks)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Time frame: From baseline to four weeks after treatment.
Changes in FEV1
Changes in FEV1 at each time point within 24 hours after administration
Time frame: From baseline to four weeks after treatment.
COPD Assessment Test (CAT)
Change From Baseline to four weeks after treatment. The score range is 0 to 40 points (0 to 10 is minor influence; 11 to 20 are moderate; 21 to 30 are classified as severe impact; 31 to 40 is very severe).
Time frame: From baseline to four weeks after treatment.
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Change From Baseline to four weeks after treatment in mMRC Scoring. The questionnaire is mainly used to evaluate the degree of respiratory distress in patients with chronic obstructive pulmonary disease. According to the symptoms of respiratory distress, the questionnaire is divided into 5 levels, with 0-1 points as less symptoms and ≥ 2 points as more symptoms.
Time frame: From baseline to four weeks after treatment.
The peak of FEV1 (two weeks)
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Changsha Third Hospital
Changsha, Hunan, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
People's Hospital of Jiangxi province
Nanchang, Jiangxi, China
The first hospital of Jilin University
Changchun, Jilin, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
...and 1 more locations
Change of the maximum value of FEV1 from baseline to two weeks after treatment
Time frame: From baseline to two weeks after treatment.
Trough FEV1
Change of trough FEV1 from baseline to two weeks after treatment.
Time frame: From baseline to two weeks after treatment.
Average FEV1 within 3 hours
Average FEV1 within 3 hours after administration
Time frame: From baseline to two weeks after treatment
Frequency of Rescue medication
Frequency of Rescue medication used group during the study in the experimental compared to that in the placebo group.
Time frame: From baseline to four weeks after administration.
Plasma drug peak concentration (Cmax)
Plasma drug peak concentration after administration.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax) after administration.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Area Under Curve (AUC)
Area under the drug concentration-time curve.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Elimination half-life (t1/2)
Apparent terminal elimination half-life after drug administration.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Apparent volume of distribution (Vd)
Apparent volume of distribution after drug administration.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Clearance (CL)
The total drug clearance rate of liver, kidney, etc.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Minimum concentration (Cmin)
Plasma drug minimum concentration after administration.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Degree of fluctuation (DF)
The ratio of the difference between Cmax,ss and Cmin,ss to Cav,ss.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Steady state volume of distribution (Vss)
Steady state volume of distribution after administration.
Time frame: Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Number of cases of adverse events
Number of cases of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time frame: From baseline to four weeks after treatment.
Incidence of adverse events
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time frame: From baseline to four weeks after treatment.
Number of cases of serious adverse events.
Number of cases of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time frame: From baseline to four weeks after treatment.
Incidence of serious adverse events.
Incidence of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time frame: From baseline to four weeks after treatment.
Number of cases of adverse events related to study drug.
Number of cases of adverse events related to study drug assessed by CTCAE v5.0.
Time frame: From baseline to four weeks after treatment.
Incidence of adverse events related to study drug.
Incidence of adverse events related to study drug assessed by CTCAE v5.0.
Time frame: From baseline to four weeks after treatment.
The peak of FEV1 (Day 1).
Change of the maximum value of FEV1 from baseline to Day 1.
Time frame: From baseline to Day 1.
The peak of FEV1 (Day 1 to 4 weeks)
Change of the maximum value of FEV1 from Day 1 to four weeks after treatment
Time frame: From Day 1 to four weeks after treatment.
Average FEV1 (Day 2)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Time frame: From baseline to 24 hours after first treatment.
Average FEV1 (Day 1 to 4 weeks)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Time frame: From Day 1 to four weeks after treatment.