A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: 3mg TQC3721 Suspension for Inhalation; Drug: 6mg TQC3721 Suspension for Inhalation; Drug: Placebo TQC3721 suspension for inhalation

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Fuyang, Anhui, China, 236000
      • Fu Yang People's Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Chongqing University Fuling Hospital
  • Fujian
    • Xiamen, Fujian, China, 361021
      • The Second Affiliated Hospital of Xiamen Medical College
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital of Guangzhou Medical University
  • Guangxi
    • Nanning, Guangxi, China, 530016
      • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Zunyi Medical University Affiliated Hospital
  • Hebei
    • Cangzhou, Hebei, China, 61012
      • Cangzhou Hospital of Integrated TCM-WM·Hebei
    • Shijiazhuang, Hebei, China, 050051
      • The Third Hospital of Hebei Medical University
  • Henan
    • Puyang, Henan, China, 457001
      • Puyang Oilfield General Hospital
    • Shangqiu, Henan, China, 476000
      • Shangqiu First People's Hospita
  • Inner Mongolia Autonomous Region
    • Chifeng, Inner Mongolia Autonomous Region, China, 024000
      • Chifeng Municipal Hospital
  • Jiangsu
    • Wuxi, Jiangsu, China, 214200
      • Yixing People's Hospital
    • Wuxi, Jiangsu, China, 214000
      • Wuxi Fifth People's Hospital
    • Yangzhou, Jiangsu, China, 225000
      • Northern Jiangsu People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130031
      • The First Hospital of Jilin University
    • Siping, Jilin, China, 136099
      • Siping Central People's Hospital
  • Liaoning
    • Panjin, Liaoning, China, 100007
      • Genertec Liaoyou Gem Flower Hospital
  • Shandong
    • Heze, Shandong, China, 274031
      • Heze Municipal Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 20025
      • Shanghai JiaoTong University of medicine Ruijin Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • West China Hospital of Sichuan University
    • Suining, Sichuan, China, 629000
      • Suining Central Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300142
      • Tianjin 4th Center Hospital
    • Tianjin, Tianjin, China, 300041
      • Tianjin Medical University General Hospital
  • Xinjiang
    • Shihezi, Xinjiang, China, 832000
      • The First Affiliated Hospital of Shihezi University
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Wenzhou University Affiliated Second Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sign informed consent before the test and fully understand the test content, process and possible adverse reactions.
• Male and female subjects aged 40 to 80 years old (including the cut-off value).
• Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value)
• Subjects have no pregnancy plan and voluntarily use effective contraception for at least 1 month from screening to the last use of the study drug.
• Diagnosed as a COPD patient according to the The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria.
• Able to conduct acceptable and reproducible lung function tests.
• COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit.
• Smoking history ≥ 10 pack years.

Exclusion Criteria:

• History of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation.
• Screening for COPD acute exacerbations that require systemic hormone therapy prior to the visit.
• Screening for hospitalization history due to COPD within the first 6 months.
• Use antibiotics for respiratory tract infections within 6 weeks prior to screening or randomization visit.
• Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD.
• Previous lung resection or lung reduction surgery.
• Pulmonary rehabilitation treatment.
• Previously received TQC3721 treatment.
• Patients who received immunotherapy within the first 4 weeks of the screening period.
• The patient has a history of diseases that are currently beyond their control.
• History or current evidence of cardiovascular disease with clinical significance.
• History of cured or untreated malignant tumors in any organ or system within the past 5 years.
• Screening for clinically significant safety laboratory test outliers determined by the researcher during the visit.
• Those who require oxygen therapy or intermittent oxygen therapy.
• Receive attenuated live vaccine within 28 days prior to randomization, inactivated vaccine within 7 days, or study.
• Planned vaccine recipients during the period.
• Individuals who have participated in any drug or medical device clinical trials prior to screening.
• Researchers believe that there are other situations that are not suitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3mg TQC3721 Suspension for Inhalation (Twice a day); Two syringes of TQC3721 suspension for inhalation (1ml:1.5mg), twice a day for 4 weeks.	Drug: 3mg TQC3721 Suspension for Inhalation; TQC3721 suspension for inhalation is target inhibitor.
Experimental: 6mg TQC3721 Suspension for Inhalation (Twice a day); one syringe of TQC3721 suspension for inhalation（1ml:6mg）and one TQC3721 suspension placebo for inhalation (1ml:0mg), twice a day for 4 weeks.	Drug: 6mg TQC3721 Suspension for Inhalation; TQC3721 suspension for inhalation is target inhibitor.
Placebo Comparator: Placebo for TQC3721 Suspension for Inhalation (Twice a day); Two syringes of placebo for TQC3721 suspension for inhalation (1ml:0mg), twice a day for 4 weeks.	Drug: Placebo TQC3721 suspension for inhalation; Placebo without active drug substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to four weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the mean value of FEV1	Compared with baseline, the mean value of FEV1 was changed within 3 hours and 12 hours after morning medication at 4 weeks of treatment.	From baseline to four weeks after treatment
Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration	Compared with baseline, Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration after 2 weeks of treatment.	From baseline to two weeks after treatment
Rescue medication	Frequency of Rescue medication use during the study compared to placebo group	From baseline to four weeks after administration
Adverse Events (AE)	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.	From baseline to safety visit (about 5 weeks after first dosing).
Changes in the peak value of FEV1，mean value of FEV1 within 3 hours and 12 hours after administration	Compared with baseline, changes in the peak value of FEV1 after 1 day of treatment, and the mean value of FEV1 within 3 hours and 12 hours after administration.	From baseline to 1day after treatment
Changes of FEV1 at each time point	Changes in series FEV1 at each time point within 12 hours after morning administration on day 1 of treatment (after first dosing) compared to baseline.	From baseline to 1day after treatment
Changes in peak value of FEV1 and the mean value of FEV1 within 3 hours and 12 hours	To evaluate the change in FEV1 peak value and FEV1 mean value within 3 hours and 12 hours after 4 weeks of treatment compared with 1 day of treatment (after first administration)	From 1day after treatment to 4 weeks after treatment
Changes in Morning Valley FEV1	Changes in Morning Valley FEV1 after 4 weeks of treatment compared with baseline	From baseline to four weeks after treatment
Changes in Modified Medical Research Council (mMRC) Dyspnea Scale Score	mMRC Dyspnea Scale Score's total score is 0-4 points, with the higher score meaning the more severe symptoms.	Changes in mMRC score after 2 and 4 weeks of treatment compared with baseline
Chronic obstructive pulmonary disease Assessment Test (CAT)	There are 8 questions in the CAT, and each question is scored 0-5 points, with the higher score meaning the more severe symptoms	Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline
St. George's Respiratory Questionnaire (SGRQ)	SGRQ has three parts: symptoms, abilities, and effects, and is used to comprehensively measure the physical, mental, and social status of COPD patients.	Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline
Basic Dyspnea Index (BDI)	BDI has three levels: functional impairment, magnitude of task, and magnitude of effort. Each level is rated from 0 (severe) to 4(No damage).	Changes in BDI after 2 and 4 weeks of treatment compared with baseline.
Transitional Dyspnea Index (TDI)	TDI has three levels:changes in functional impairment, changes in magnitude of task, changes in magnitude of effort,. Scores in each area range from -3 (significant deterioration) to 0 (no change) to +3 (significant improvement).	Changes in TDI after 2 and 4 weeks of treatment compared with baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2024
• Primary Completion (Actual): January 16, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TQC3721-II-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No