A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to very severe COPD
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• Males and females of Chinese ethnicity, at least 40 years of age.
• Patients with with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to according to GOLD criteria 2023.
• Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) \< 0.70 at visit 1.
• Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.
Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2025-10
Participants
Target number of participants: 474
Treatments
Experimental: HL231 Solution for Inhalation
Active_comparator: Ultibro
Related Therapeutic Areas
Sponsors
Collaborators: Sichuan Haisco Pharmaceutical Group Co., Ltd
Leads: Haisco Pharmaceutical Group Co., Ltd.