Evaluating a new treatment for COPD in Chinese adults

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

This study is testing a new medication called 611 to see if it can help Chinese adults with moderate to severe COPD feel better and have fewer flare-ups.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Beijing, Beijing and 2 other locations)
• Trial ID: NCT06099652 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of a new medication, 611, in Chinese adults suffering from moderate to severe chronic obstructive pulmonary disease (COPD). Participants will undergo a maximum study duration of 28 weeks, which includes a 4-week screening period, a 16-week randomized treatment phase with either 611 or a placebo, and an 8-week follow-up. The study will focus on individuals with a documented history of COPD and specific lung function criteria. The goal is to determine if 611 can improve symptoms and reduce exacerbations in this patient population.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 40 to 85 with moderate to severe COPD and a history of exacerbations.

Not a fit: Patients with mild COPD or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and management of COPD for patients.

How similar studies have performed: Other studies have shown promise in treating COPD with novel therapies, suggesting potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
2. Male or female adults ages 40 to 85 years old when signing the informed consent.
3. BMI≥16 kg/m2.
4. Documented diagnosis of COPD for at least one year prior to enrolment.
5. Post-bronchodilator FEV1/FVC \< 0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%.
6. Current or former smokers with a smoking history of ≥10 pack-years or environmental exposure to biofuel fumes ≥10 years
7. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
8. Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
9. Patients with blood eosinophils ≥200 cells/microliter at screening.
10. Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.

Exclusion Criteria:

1. Significant pulmonary disease other than COPD (e.g., active tuberculosis，lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, etc)
2. Diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
3. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
4. Diagnosis of α-1 anti-trypsin deficiency.
5. Cor pulmonale, evidence of right cardiac failure
6. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
7. A participant with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.
8. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
9. Hypercapnia requiring Bi-level ventilation.
10. AECOPD as defined in inclusion criteria within 4 weeks prior to screening or randomization.
11. History of, or planned pneumonectomy or lung volume reduction surgery.
12. Treatment with oxygen of more than 12 hours per day.
13. Known with allergic or intolerant to mometasone furoate spray or 611/placebo.
14. Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Where this trial is running

Beijing, Beijing and 2 other locations

• China-Japan Friendship Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
• Zhongshan Hospital affiliated to Fudan University — Shanghai, Shanghai, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Qinghong Zhou, BS

Conditions Pulmonary Disease, Chronic Obstructive