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

December 15, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in morning pre-dose trough FEV1 at week 12
Time Frame: Up to week 12
Up to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in morning pre-dose trough FEV1 at each time point
Time Frame: up to week 48
up to week 48
Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point
Time Frame: up to week 48
up to week 48
Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
Time Frame: up to week 48
up to week 48
Peak change from baseline in FEV1 at week 12
Time Frame: Up to 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
Time Frame: Up to week 12
Up to week 12
Rate of moderate or severe COPD exacerbations over 48 Weeks
Time Frame: up to week 48
up to week 48
Rate of severe COPD exacerbations over 48 Weeks
Time Frame: up to week 48
up to week 48
Change from baseline in CAT (COPD Assessment test) total score at each time point
Time Frame: up to week 48
up to week 48
Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point
Time Frame: up to week 48
up to week 48
Incidence and severity of adverse events
Time Frame: Up to week 50
Up to week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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