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

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.
• •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.