Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstruct… (NCT07464587) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
China800 participantsStarted 2026-03
Plain-language summary
To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Cohort A:
* Subjects who have completed the TQC3721-III-01 clinical trial, demonstrated good medication compliance during the 24-week treatment period as required by the protocol (with no major protocol deviations related to medication compliance), and experienced no treatment-related SAEs.
* Sign the informed consent form and fully understand the trial content, procedures, and potential adverse reactions.
* Willing and able to comply with the trial arrangements and to use the nebulizer correctly.
* Subjects have no pregnancy plans from screening until at least 1 month after the last dose of the investigational drug and voluntarily adopt effective contraception measures.
* Patients with a clear clinical history and related symptoms of COPD (meeting the diagnostic criteria for COPD as outlined in the Chinese Guidelines for the Diagnosis and Management of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)).
Cohort B:
* Sign the informed consent form prior to screening and fully understand the trial content, procedures, and potential adverse reactions.
* Willing and able to comply with the trial arrangements and to use the nebulizer correctly.
* Aged between 40 and 80 years (inclusive), both male and female subjects are eligible.
* Subjects have no pregnancy plans from screening until at least 1 month after the last dose of the investigational drug and voluntarily adopt effective contraception measures.
* Patients with a clear clinical history a…
What they're measuring
1
Adverse event rate
Timeframe: Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment
2
Number of subjects with laboratory abnormalities
Timeframe: Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment
Trial details
NCT IDNCT07464587
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.