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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: HRG2005 inhalation; Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation; Drug: Placebo to match HRG2005 inhalation; Drug: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol;
2. Subjects 40 years of age or older (inclusive), Male or female subjects;
3. Subjects with an established clinical history of COPD;
4. A post-bronchodilator FEV1/FVC ratio must be <0.7 at Screening and FEV1 must be <80% and ≥30% predicted normal at pre-randomization;
5. a documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbation in the previous 12 months;
6. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking;
7. A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization.

Exclusion Criteria:

1. Subjects who required systemic corticosteroids or antibiotics or hospitalized due to poorly controlled COPD or who had lower respiratory tract infections that required antibiotics within 4 weeks prior to Screening to pre-randomization;
2. Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening to pre-randomization;
3. Subjects with other respiratory or respiratory related diseases, including but not limited to asthma, active tuberculosis, lung cancer, interstitial pulmonary disease, α1-antitrypsin deficiency, pulmonary heart disease, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary disease;
4. Subjects with lung volume reduction surgery within the 12 months prior to Screening;
5. Subjects who have Other known serious medical conditions；
6. Subjects receiving oxygen therapy required for greater than 15 hours a day;
7. Clinically significant electrocardiogram abnormality；
8. Subjects with significant laboratory abnormality at screening；
9. Suspected allergy to any ingredient in the study drug;
10. Participation in clinical trials of any drug or medical device (except for screening failures) within 4 weeks before screening, or within 5 half-lives of the drug at screening (whichever is longer);
11. Pregnant or lactating females;
12. History of drug abuse within one year before screening
13. Other conditions judged by the investigator to be not suitable to participate in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; Drug1 dose 1+Drug 3	Drug: HRG2005 inhalation; Drug 1: dose 1; dose 2; dose 3; Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation; Drug 3
Experimental: Treatment group B; Drug1 dose 2+Drug 2+Drug 3	Drug: HRG2005 inhalation; Drug 1: dose 1; dose 2; dose 3; Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation; Drug 3; Drug: Placebo to match HRG2005 inhalation; Drug 2
Experimental: Treatment group C; Drug1 dose 3+Drug 2+Drug 3	Drug: HRG2005 inhalation; Drug 1: dose 1; dose 2; dose 3; Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation; Drug 3; Drug: Placebo to match HRG2005 inhalation; Drug 2
Other: Treatment group D; Drug 2+Drug 4	Drug: Placebo to match HRG2005 inhalation; Drug 2; Drug: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation; Drug 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in morning pre-dose trough FEV1 at week 12	Up to week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in morning pre-dose trough FEV1 at each time point	up to week 48
Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point	up to week 48
Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1	up to week 48
Peak change from baseline in FEV1 at week 12	Up to week 12
FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12	Up to week 12
Rate of moderate or severe COPD exacerbations over 48 Weeks	up to week 48
Rate of severe COPD exacerbations over 48 Weeks	up to week 48
Change from baseline in CAT (COPD Assessment test) total score at each time point	up to week 48
Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point	up to week 48
Incidence and severity of adverse events	Up to week 50

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): February 17, 2025
• Study Completion (Actual): February 17, 2025

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Circulatory and Respiratory Physiological Phenomena; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Inhalation
• Other Study ID Numbers: HRG2005-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No