NCT06035393

A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Phase II, Randomized, Double Blind, Double Dummy, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, double dummy, active-controlled, parallel-group study to assess the efficacy and Safety of HRG2005 inhalation in patients with moderate to severe chronic obstructive pulmonary disease. Approximately 200 patients with moderate to severe COPD will be randomized into the study.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	HRG2005 inhalation	Drug 1: dose 1; dose 2; dose 3
DRUG	Placebo to match HRG2005 inhalation	Drug 2
DRUG	Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation	Drug 3
DRUG	Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation	Drug 4

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-02-17
• Completion: 2025-02-17
• First posted: 2023-09-13
• Last updated: 2025-12-22

Locations

1 site across 1 country: China