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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-85
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.

Male or female adults ages 40 to 85 years old when signing the informed consent.

Current or former smokers with a smoking history of ≥10 pack-years.

Documented diagnosis of COPD for at least 12 months prior to enrolment

Disqualifiers

Presence of a known pre-existing, clinically important lung condition other than COPD.

A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.

Diagnosis of α-1 anti-trypsin deficiency.

Presence of an active autoimmune disease.

Trial design

Treatments tested in this trial

  • 611
  • Placebo

Treatment groups

594 Participants
are divided into 2 treatment groups