Clinical trial NCT06527144: A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change of the maximum value of Forced Expiratory Volume in the first second (FEV1)
timeFrame: From baseline to four weeks after treatment
Secondary outcomes:
measure: Change of the mean value of FEV1
timeFrame: From baseline to four weeks after treatment
measure: Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration
timeFrame: From baseline to two weeks after treatment
measure: Rescue medication
timeFrame: From baseline to four weeks after administration
measure: Adverse Events (AE)
timeFrame: From baseline to safety visit (about 5 weeks after first dosing).
measure: Changes in the peak value of FEV1，mean value of FEV1 within 3 hours and 12 hours after administration
timeFrame: From baseline to 1day after treatment
measure: Changes of FEV1 at each time point
timeFrame: From baseline to 1day after treatment
measure: Changes in peak value of FEV1 and the mean value of FEV1 within 3 hours and 12 hours
timeFrame: From 1day after treatment to 4 weeks after treatment
measure: Changes in Morning Valley FEV1
timeFrame: From baseline to four weeks after treatment
measure: Changes in Modified Medical Research Council (mMRC) Dyspnea Scale Score
timeFrame: Changes in mMRC score after 2 and 4 weeks of treatment compared with baseline
measure: Chronic obstructive pulmonary disease Assessment Test (CAT)
timeFrame: Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline
measure: Basic Dyspnea Index (BDI)
timeFrame: Changes in BDI after 2 and 4 weeks of treatment compared with baseline.
measure: Transitional Dyspnea Index (TDI)
timeFrame: Changes in TDI after 2 and 4 weeks of treatment compared with baseline
Other outcomes:
Locations:
city: Fuyang
country: China
facility: Fu Yang People'S Hospital
state: Anhui
city: Chongqing
country: China
facility: ChongQing University Fuling Hospital
state: Chongqing
city: Xiamen
country: China
facility: The Second Affiliated Hospital of Xiamen Medical College
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Zunyi
country: China
facility: Zunyi Medical University Affiliated Hospital
state: Guizhou
city: Cangzhou
country: China
facility: Cangzhou Hospital of Integrated Tcm-Wm·Hebei
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Shangqiu
country: China
facility: Shangqiu First People's Hospita
state: Henan
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Inner Mongolia Autonomous Region
city: Wuxi
country: China
facility: Wuxi Fifth People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Yixing People'S Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Siping
country: China
facility: Siping Central People's Hospital
state: Jilin
city: Panjin
country: China
facility: Genertec Liaoyou Gem Flower Hospital
state: Liaoning
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai JiaoTong University of medicine Ruijin Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: TianJin 4th Center Hospital
state: Tianjin
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University
state: Xinjiang
city: Wenzhou
country: China
facility: Wenzhou University Affiliated Second Hospital
state: Zhejiang
Study officials:
References: