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NCT07147946

PHASE3

Evaluation of the Clinical Trial of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)

Official title: Evaluation of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

666

Start Date

2025-09

Completion Date

2027-06

Last Updated

2025-09-10

Healthy Volunteers

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

DRUG

TQC3721 Suspension for inhalation

TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor

DRUG

Placebo of TQC3721 Suspension for Inhalation

Placebo without drug substance

Inclusion Criteria: 1. Sign an informed consent form before screening and fully understand the trial content, process, and potential adverse reactions. 2. Comply with the experimental schedule and be able to use the nebulizer inhaler correctly. 3. The age range is 40 to 80 years old (including the threshold), and both male and female participants are eligible. 4. The subjects have no pregnancy plans and voluntarily take effective contraceptive measures for at least one month from screening to the last use of the study drug. 5. Patients with a clear clinical history and related symptoms of COPD before screening. 6. Capable of conducting acceptable and reproducible lung function tests. 7. COPD clinical stability (no moderate to severe COPD acute exacerbation) within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit. 8. Smoking history ≥ 10 pack years. Exclusion Criteria: 1. A history of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation. 2. COPD acute exacerbations requiring systemic hormone therapy within 3 months prior to screening visit (V1 visit) or prior to randomization visit (V2 visit). 3. Within the first 6 months of screening, there has been at least 1 hospitalization history due to acute exacerbation of COPD or pneumonia. 4. Treatment with antibiotics for upper and/or lower respiratory tract infections within 6 weeks prior to screening or randomization visit (V3 visit). 5. Simultaneously suffering from other respiratory diseases. 6. Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD. 7. Previous lung resection or lung reduction surgery. 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.

Locations (76)

Bozhou People's Hospital

Bozhou, Anhui, China

Chizhou People's Hospital

Chizhou, Anhui, China

Chaohu Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Peolpe's Hospital Of Chongqing Banan District

Chongqing, Chongqing Municipality, China

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

Fuling Hospital Affiliated to Chongqing University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

The Eighth Affiliated Hospital of Southern Medical University（The First people's Hospital of Shunde ）

Foshan, Guangdong, China

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Cangzhou Hospital of Integrated TCM- WM·HEBEI

Cangzhou, Hebei, China

Hebei PetroChina Central Hospital

Langfang, Hebei, China

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Daqing Longnan Hospital

Daqing, Heilongjiang, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Qiqihar First Hospital

Qiqihar, Heilongjiang, China

Jiaozuo Second People's Hospital

Jiaozuo, Henan, China

Puyang Oilfield General Hospital

Puyang, Henan, China

The First People's Hospital of Shangqiu

Shangqiu, Henan, China

Yichang Central People's Hospital

Yichang, Hubei, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China

Inner Mongolia Medical University Affiliated Hospital

Hohhot, Inner Mongolia, China

Nanjing Jiangning Hospital

Nanjing, Jiangsu, China

The Fifth People's Hospital of Wuxi

Wuxi, Jiangsu, China

Jiangyin Hospital of Traditional Chinese Medicine

Wuxi, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, China

Yixing People's Hospital

Yixing, Jiangsu, China

Jiujiang First People's Hospital

Jiujiang, Jiangxi, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The first hospital of Jilin University

Changchun, Jilin, China

Central Hospital of Dalian University of Technology

Dalian, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Qinghai Provincial People's Hospital

Xining, Qinghai, China

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, China

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, China

Binzhou People's Hospital

Binzhou, Shandong, China

Heze Municipal Hospital

Heze, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Weifang NO.2 People's Hospital

Weifang, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Baoji Central Hospital

Baoji, Shanxi, China

Changzhi People's Hospital

Changzhi, Shanxi, China

Yangquan coal Industry(Group) General Hospital

Yangquan, Shanxi, China

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Chengdu Second People's Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Mianyang Hospital of Traditional Chinese Medicine

Mianyang, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin 4th Center Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, China

The Second Hospital of Jiaxing

Jiaxing, Zhejiang, China

Jinhua municipal central hospital

Jinhua, Zhejiang, China

Dongyang People's Hospital

Jinhua, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Taizhou Central Hospital

Taizhou, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Clinical Research Directory

Evaluation of the Clinical Trial of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (76)