RecruitingPhase 3NCT07039669

Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease


Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

594 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new inhaled medication called 611 in Chinese adults with moderate to severe COPD (chronic obstructive pulmonary disease), a lung condition that causes breathing difficulties, to see if it improves lung function. **You may be eligible if...** - You are between 40 and 85 years old - You have had a confirmed COPD diagnosis for at least 12 months - You are a current or former smoker with at least a 10 pack-year smoking history - Your breathing test results confirm moderate to severe COPD **You may NOT be eligible if...** - You have asthma or other lung diseases that are not COPD - You have had a severe COPD flare-up in the past 3 months - You have serious heart or kidney conditions that could be affected by the medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG611

611 subcutaneous (SC) injection

DRUGPlacebo

placebo Q2W, subcutaneous (SC) injection


Locations(4)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07039669


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