RecruitingPhase 2NCT07252908

A Phase II Clinical Trial on the Efficacy and Safety of TQC3721 Inhalation Powder

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC3721 Inhalation Powder in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

195 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Disease, Chronic Obstructive

Summary

To evaluate the efficacy and safety of TQC3721 inhalation powder in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This phase II study tests a new inhaled powder medication called TQC3721 in adults with moderate-to-severe COPD (chronic obstructive pulmonary disease, a lung condition that makes breathing difficult). The study aims to assess whether it improves lung function and reduces breathlessness compared to existing treatments. **You may be eligible if...** - You are between 40 and 80 years old - You have been diagnosed with COPD for at least 1 year - Your lung function tests confirm moderate-to-severe COPD (specific breathing test values) - You have a smoking history of at least 10 pack-years - You experience significant breathlessness (mMRC score ≥2) - You have been on stable COPD inhalers for at least 4 weeks - Your COPD has been stable for at least 4 weeks before screening **You may NOT be eligible if...** - Your COPD has flared up recently and required steroids within the past 3 months - You were hospitalized for COPD or pneumonia in the past 6 months - You have other lung diseases such as asthma, lung cancer, or pulmonary fibrosis - You have severe heart problems (recent heart attack, severe arrhythmia, NYHA Class III–IV heart failure) - You have had major surgery recently or are planning surgery soon - You are pregnant or breastfeeding - You have active HIV, hepatitis B or C, or syphilis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQC3721 inhalation powder

TQC3721 inhalation powder is target inhibitor.

DRUGPlacebo for TQC3721 inhalation powder

Placebo for TQC3721 inhalation powder.

Locations(29)

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

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Yixing People'S Hospital

Wuxi, Jiangsu, China

Jiujiang First People's Hospital

Jiujiang, Jiangxi, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Siping Central People's Hospital

Siping, Jilin, China

Heze Municipal Hospital

Heze, Shandong, China

Shanghai JiaoTong University of medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Linfen People's Hospital

Linfen, Shanxi, China

Nuclear Industry 416 Hospital

Chengdou, Sichuan, China

Chengdu Fifth People's Hospital

Chengdu, Sichuan, China

Affiliated Hospital Of ChengDu University

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

The Fourth Central Hospital of Tianjin

Tianjin, Tianjin Municipality, China

Taizhou central hospital (Taizhou university hospital）

Taizhou, Zhejiang, China

The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU

Wenzhu, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07252908

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