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A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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.

NCT05987371•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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;
+2 more criteria

Exclusion Criteria

•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:
•1. 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.
•2. Known COVID-19 infection history within 4 weeks before screening (V1);
•3. Known medical history of hospitalization due to COVID-19 within 3 months before screening (V1);
•4. Subjects who had COVID-19 infection before screening (V1) and had not fully recovered to participate in clinical trial operations.
+24 more criteria

Locations (11)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Wuhan Sixth Hospital

Wuhan, Hubei, China

Changsha Third Hospital

Changsha, Hunan, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

People's Hospital of Jiangxi province

Nanchang, Jiangxi, China

The first hospital of Jilin University

Changchun, Jilin, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Key Dates

Start Date

August 23, 2023

Primary Completion Date

January 16, 2024

Completion Date

April 23, 2024

Last Updated

April 17, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

TQC3721 suspension for inhalation

DRUG

TQC3721 matching placebo for inhalation

DRUG

Salbutamol sulfate inhalation aerosol

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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