A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
Randomized, Double-blind, Placebo-controlled, Dose Exploration, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
1 other identifier
interventional
75
1 country
11
Brief Summary
This is a phase II clinical trial to evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease
Started Aug 2023
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2024
CompletedApril 17, 2025
April 1, 2025
5 months
August 4, 2023
April 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The peak of Forced Expiratory Volume in the 1st second (FEV1) (4 weeks)
Change of the maximum value of FEV1 from baseline to four weeks after treatment
From baseline to four weeks after treatment.
Secondary Outcomes (29)
Morning trough FEV1
From baseline to four weeks after treatment.
Average FEV1 (4 weeks)
From baseline to four weeks after treatment.
Changes in FEV1
From baseline to four weeks after treatment.
COPD Assessment Test (CAT)
From baseline to four weeks after treatment.
Modified Medical Research Council (mMRC) Dyspnea Scale Score
From baseline to four weeks after treatment.
- +24 more secondary outcomes
Study Arms (4)
TQC3721 Suspension for Inhalation (Twice a day)+ Salbutamol
EXPERIMENTALTQC3721 suspension for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
TQC3721 Suspension for Inhalation (Once a day)+ Salbutamol
EXPERIMENTALTQC3721 suspension for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
TQC3721 matching placebo for inhalation (Twice a day)+ Salbutamol
PLACEBO COMPARATORTQC3721 suspension placebo for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
TQC3721 matching placebo for inhalation (once a day)+ Salbutamol
PLACEBO COMPARATORTQC3721 suspension placebo for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
Interventions
TQC3721 suspension for inhalation is a dual inhibitor targeting PDE3/4.
Placebo without active substance.
Salbutamol is short-acting β2 receptor agonists.
Eligibility Criteria
You may qualify if:
- Sign an informed consent form before the study and fully understand the content, process, and potential adverse reactions of the experiment;
- Capable of using the study nebulizer correctly and complying with all study restrictions and procedures;
- Aged between 30 and 75 years old (Including critical values), both men and women;
- Body mass index(BMI) within the range of 18-30 kg/m2 (Including critical values);
- The subject has no pregnancy plan and voluntarily adopts effective contraceptive measures for at least one month from screening until the last use of the study drug;
- Diagnosed as a COPD patient according to the Global initiative for chronic obstructive lung disease (GOLD) 2023 standard, and had symptoms that met COPD for at least 1 year before screening;
- Able to conduct acceptable and repeatable lung function measurements;
- Clinical stability of COPD within 4 weeks before screening visit (V1) and between V1 visit and V2 visit;
- Long acting Bronchiectasis or short acting Bronchiectasis were not regularly used at least 14 days before screening visit (V1);
- Long acting Bronchiectasis can be stopped during the study until the end of the study, and short acting Bronchiectasis can be stopped at least 6 hours before the pulmonary function test;
- Meet the restrictions on combination medication and expect to maintain the restrictions during treatment;
- Current smoking or smoking history ≥ 10 pack years (smoking at least 20 cigarettes per day for 10 consecutive years or smoking at least 10 cigarettes per day for 20 consecutive years, former cigarette smokers must stop smoking\>6 months before visit 1).
You may not qualify if:
- A history of life-threatening COPD, including hospitalization in an intensive care unit and/or the need for intubation.
- Acute exacerbations of COPD requiring oral or parenteral steroid treatment within 3 months before screening (V1) or before randomization (V2).
- Received inhaled corticosteroids (ICS) treatment within 4 weeks prior to screening.
- Have a history of hospitalization for COPD at least once within 6 months prior to screening.
- Antibiotic treatment for upper and/or lower respiratory tract infection within 6 weeks before screening or before randomized visit (V2). Note: Patients with a history of upper/lower respiratory tract infection within 6 weeks cannot participate in the test, but can be re-screened 6 weeks after the infection is cured.
- COVID-19:
- Suspected or confirmed COVID-19 infection during screening (V1), confirmed by the laboratory or based on the medical judgment of the researcher; Subjects who are known to have contact with COVID-19 positive patients. Note: Subjects should remain Asymptomatic for 14 days or more after exposure, and only after being approved by the investigator can they be re-screened.
- Known COVID-19 infection history within 4 weeks before screening (V1);
- Known medical history of hospitalization due to COVID-19 within 3 months before screening (V1);
- Subjects who had COVID-19 infection before screening (V1) and had not fully recovered to participate in clinical trial operations.
- Suffering from other respiratory diseases simultaneously: α- 1. Antitrypsin deficiency, primary ciliary dyskinesia, lung cancer; Respiratory diseases such as active pulmonary infection, pulmonary tuberculosis, Bronchiectasis, Pulmonary fibrosis, pulmonary Sarcoidosis, pulmonary hypertension, etc. with significant clinical significance assessed by the researchers.
- Chest computed tomography (CT) has found clinically significant abnormalities and believes that the abnormalities are not caused by COPD, and the researchers have determined that they have an impact on the trial results or patient safety. If there is no chest CT report within 3 months before visit 1, a chest CT examination must be performed on visit 1.
- Previously underwent pneumonectomy or lung reduction surgery.
- Previously received lung rehabilitation treatment (those who have been stable for 4 weeks before screening and have remained stable during the trial period can be selected).
- Received oral steroids or roflumilast treatment for COPD within 3 months before screening (Visit 1), or received oral theophylline and/or theophylline derivatives treatment for COPD within 1 months before screening (V1).
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524023, China
Wuhan Sixth Hospital
Wuhan, Hubei, 430015, China
Changsha Third Hospital
Changsha, Hunan, 410035, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000, China
People's Hospital of Jiangxi province
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin University
Changchun, Jilin, 130021, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
Mianyang Central Hospital
Mianyang, Sichuan, 621099, China
Suining Central Hospital
Suining, Sichuan, 629000, China
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325088, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2023
First Posted
August 14, 2023
Study Start
August 23, 2023
Primary Completion
January 16, 2024
Study Completion
April 23, 2024
Last Updated
April 17, 2025
Record last verified: 2025-04