A Phase 3 interventional study of TQC3721 Suspension for inhalation and Placebo of TQC3721 Suspension for Inhalation in Chronic Obstructive Pulmonary Disease, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Not yet recruiting at 76 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Treatment
To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 666 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
11.Previously received TQC3721 treatment. 12.Patients who received immunosuppressant therapy within 4 weeks prior to the screening period 13.In the investigator's assessment, patients are unable to discontinue the prohibited drugs specified in the protocol during the screening and treatment phases of the study; 14.Patients with a history of uncontrolled current diseases that the investigator judges to be clinically significant; 15.A history or current evidence of clinically significant cardiovascular or cerebrovascular diseases; 16.A history of malignant tumors (cured or uncured) in any organ or system within the past 5 years; 17.Intolerance or allergy to salbutamol or other inhaled bronchodilator therapies for COPD; 18.Patients requiring long-term oxygen therapy; 19.Female subjects who are currently pregnant, breastfeeding, or planning to become pregnant during the study period after enrollment; 20.Having participated in any clinical trial of drugs or medical devices within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit; 21.Other conditions deemed unsuitable for participation in the study by the investigator.
Inhalation of TQC3721 suspension (6mg/2ml), one unit dose twice daily for 24 weeks
Drug: TQC3721 Suspension for inhalation
Inhalation of TQC3721 placebo, one unit dose twice daily for 24 weeks
Drug: Placebo of TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor
Placebo without drug substance
Mean change in the area under the curve (AUC) of Forced Expiratory Volume in 1 second (FEV1)
Change from baseline in mean FEV1 AUC over 0-12 hours after 12 weeks of treatment.
Time frame: Baseline to 12 weeks after treatment
Changes in peak FEV1 value
Changes from baseline in peak FEV1 within 4 hours after morning dosing at Weeks 6, 12, and 24 of treatment.
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Changes in trough FEV1 values
Changes from baseline in morning trough FEV1 at Weeks 6, 12, and 24 of treatment.
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Average FEV1 AUC 0-4h
Change from baseline in the average FEV1 AUC 0-4h within 4 hours after morning dosing at 6, 12, and 24 weeks of treatment.
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
St. George's Respiratory Questionnaire
Changes in St. George's Respiratory Questionnaire (SGRQ) total scores from baseline at 6, 12, and 24 weeks of treatment.
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Chronic Obstructive Pulmonary Disease Assessment Test
Self-assessment for Patients with COPD：Numbers 0 to 5 indicate the severity (with 0 being the mildest and 5 being the most severe).
Time frame: At 6 weeks, 12 weeks, and 24 weeks of treatment
Average FEV1 AUC (6-12h)
Change from baseline in mean FEV₁ AUC (6-12 h) at Week 12 following dosing.
Time frame: Baseline to 12 weeks after treatment
Annual rate of acute exacerbation of COPD
The annualized rate of acute exacerbation of moderate/severe COPD after 24 weeks of treatment.
Time frame: Baseline to 24 weeks after treatment
Time of first acute exacerbation of moderate/severe COPD
The time of the first acute exacerbation of moderate/severe COPD within 24 weeks of treatment.
Time frame: Baseline to 24 weeks after treatment
Adverse event (AE)
The number of participants with AEs, serious dverse event (SAEs), drug-related AEs, and abnormal lab results.
Time frame: D-28 to within 25 weeks of treatment
Assessment of respiratory symptoms in COPD
Change from baseline in weekly mean Evaluating Respiratory Symptoms in COPD total score
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Transition Dyspnea Index (TDI) score
Change in Transition Dyspnea Index (TDI) score relative to Baseline Dyspnea Index (BDI) score
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score
Change in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score from baseline
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Change from baseline in rescue medication use
Changes from baseline in rescue medication use during treatment at Weeks 6, 12, and 24 versus the placebo group
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment.
Interleukin-6 (IL-6), Interleukin-8 (IL-8), and C-reactive protein (CRP) at Week 12 and Week 24
IL-6, IL-8, and C-reactive protein (CRP) at Week 12 and Week 24. The elevated serum C-reactive protein (CRP) levels in patients with chronic obstructive pulmonary disease (COPD) are primarily associated with pulmonary inflammatory responses.
Time frame: At Week 12 and Week 24
Plasma drug peak concentration
Perform Pharmacokinetics (PK) analysis of TQC3721 blood drug concentration data at baseline, week 6, and week 12 to evaluate the PK characteristics of TQC3721 in COPD patients.
Time frame: Day 1: 0.5 hour after-dose, Week 6: 1 hour pre-dose, 0.5 hour after-dose; Week 12: 1 hour pre-dose, 0.5 hour after-dose
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.