Chronic Obstructive Pulmonary DiseasePhase 2NCT06035393
A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study testing HRG2005 inhalation and Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation in people with Chronic Obstructive Pulmonary Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- HRG2005 inhalation and Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 17 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent and to comply with the study protocol;
- Subjects 40 years of age or older (inclusive), Male or female subjects;
- Subjects with an established clinical history of COPD;
- A post-bronchodilator FEV1/FVC ratio must be <0.7 at Screening and FEV1 must be <80% and ≥30% predicted normal at pre-randomization;
- a documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbation in the previous 12 months;
- Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking;
- A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization.
Who cannot join
- 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;
- Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening to pre-randomization;
- 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;
- Subjects with lung volume reduction surgery within the 12 months prior to Screening;
- Subjects who have Other known serious medical conditions；
- Subjects receiving oxygen therapy required for greater than 15 hours a day;
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- Clinically significant electrocardiogram abnormality；
- Subjects with significant laboratory abnormality at screening；
- Suspected allergy to any ingredient in the study drug;
- 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);
- Pregnant or lactating females;
- History of drug abuse within one year before screening
- Other conditions judged by the investigator to be not suitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- HRG2005 inhalation, Placebo to match HRG2005 inhalation, Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation, Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG2005 inhalationDrug
Drug 1: dose 1; dose 2; dose 3
Placebo to match HRG2005 inhalationDrug
Drug 2
Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug
Drug 3
Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug
Drug 4
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Drug1 dose 1+Drug 3 Receives: Drug: HRG2005 inhalation; Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation |
| Treatment group B | Experimental | Drug1 dose 2+Drug 2+Drug 3 Receives: Drug: HRG2005 inhalation; Drug: Placebo to match HRG2005 inhalation; Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation |
| Treatment group C | Experimental | Drug1 dose 3+Drug 2+Drug 3 Receives: Drug: HRG2005 inhalation; Drug: Placebo to match HRG2005 inhalation; Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation |
| Treatment group D | Other | Drug 2+Drug 4 Receives: Drug: Placebo to match HRG2005 inhalation; Drug: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in morning pre-dose trough FEV1 at week 12
Measured: Up to week 12
Secondary outcomes (10)
Change from baseline in morning pre-dose trough FEV1 at each time point
Measured: up to week 48
Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point
Measured: up to week 48
Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
Measured: up to week 48
Peak change from baseline in FEV1 at week 12
Measured: 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
Measured: Up to week 12
Rate of moderate or severe COPD exacerbations over 48 Weeks
Measured: up to week 48
Rate of severe COPD exacerbations over 48 Weeks
Measured: up to week 48
Change from baseline in CAT (COPD Assessment test) total score at each time point
Measured: up to week 48
Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point
Measured: up to week 48
Incidence and severity of adverse events
Measured: Up to week 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Jan 2024
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Why it stopped: Sponsor's R\&D strategy adjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double blind, double dummy, active-controlled, parallel-group study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035393
- Sponsor's protocol ID
- HRG2005-201
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06035393
- Acronym / sponsor ID
- HRG2005-201
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's R\&D strategy adjusted.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This is a randomized, double blind, double dummy, active-controlled, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRG2005 inhalation, Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug1 dose 1+Drug 3 |
| Treatment group B | Experimental | Drug: HRG2005 inhalation, Drug: Placebo to match HRG2005 inhalation, Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug1 dose 2+Drug 2+Drug 3 |
| Treatment group C | Experimental | Drug: HRG2005 inhalation, Drug: Placebo to match HRG2005 inhalation, Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug1 dose 3+Drug 2+Drug 3 |
| Treatment group D | Other | Drug: Placebo to match HRG2005 inhalation, Drug: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug 2+Drug 4 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to provide written informed consent and to comply with the study protocol;
- Subjects 40 years of age or older (inclusive), Male or female subjects;
- Subjects with an established clinical history of COPD;
- A post-bronchodilator FEV1/FVC ratio must be <0.7 at Screening and FEV1 must be <80% and ≥30% predicted normal at pre-randomization;
- a documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbation in the previous 12 months;
Key exclusion criteria (13 listed)
- 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;
- Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening to pre-randomization;
- 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;
- Subjects with lung volume reduction surgery within the 12 months prior to Screening;
- Subjects who have Other known serious medical conditions；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRG2005 inhalationDrug 1: dose 1; dose 2; dose 3 | Drug | Treatment group A, Treatment group B, Treatment group C |
| Placebo to match HRG2005 inhalationDrug 2 | Drug | Treatment group B, Treatment group C, Treatment group D |
| Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug 3 | Drug | Treatment group A, Treatment group B, Treatment group C |
| Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalationDrug 4 | Drug | Treatment group D |
Primary outcome
Change from baseline in morning pre-dose trough FEV1 at week 12
Time frame: Up to week 12
10 secondary outcomes
Change from baseline in morning pre-dose trough FEV1 at each time point
Time frame: 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
Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
Time frame: up to week 48
Peak change from baseline in FEV1 at week 12
Time frame: 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
Rate of moderate or severe COPD exacerbations over 48 Weeks
Time frame: up to week 48
Rate of severe COPD exacerbations over 48 Weeks
Time frame: up to week 48
Change from baseline in CAT (COPD Assessment test) total score at each time point
Time frame: 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
Incidence and severity of adverse events
Time frame: Up to week 50
Results and safety
The study was stopped early (reason given: Sponsor's R\&D strategy adjusted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRG2005 inhalation and Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation in people with Chronic Obstructive Pulmonary Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's R\&D strategy adjusted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in morning pre-dose trough FEV1 at week 12 (time frame: Up to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.