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TerminatedNCT06035393Updated Dec 22, 2025

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

A Phase 2 interventional study of HRG2005 inhalation and Placebo to match HRG2005 inhalation in Chronic Obstructive Pulmonary Disease, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Terminated at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor's R\&D strategy adjusted.
Phase
Phase 2
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 82 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Treatment group A

    Drug1 dose 1+Drug 3

    Drug: HRG2005 inhalation · Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

  • Experimental
    Treatment group B

    Drug1 dose 2+Drug 2+Drug 3

    Drug: HRG2005 inhalation · Drug: Placebo to match HRG2005 inhalation · Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

  • Experimental
    Treatment group C

    Drug1 dose 3+Drug 2+Drug 3

    Drug: HRG2005 inhalation · Drug: Placebo to match HRG2005 inhalation · Drug: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

  • Other
    Treatment group D

    Drug 2+Drug 4

    Drug: Placebo to match HRG2005 inhalation · Drug: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

Interventions

  • DrugHRG2005 inhalation

    Drug 1: dose 1; dose 2; dose 3

  • DrugPlacebo to match HRG2005 inhalation

    Drug 2

  • DrugPlacebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

    Drug 3

  • DrugIndacaterol Maleate and Glycopyrronium Bromide Powder for inhalation

    Drug 4

06

What researchers measure

Primary outcomes

  1. Change from baseline in morning pre-dose trough FEV1 at week 12

    Time frame: Up to week 12

Secondary outcomes

  1. Change from baseline in morning pre-dose trough FEV1 at each time point

    Time frame: up to week 48

  2. Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point

    Time frame: up to week 48

  3. Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1

    Time frame: up to week 48

  4. Peak change from baseline in FEV1 at week 12

    Time frame: Up to week 12

  5. 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

  6. Rate of moderate or severe COPD exacerbations over 48 Weeks

    Time frame: up to week 48

  7. Rate of severe COPD exacerbations over 48 Weeks

    Time frame: up to week 48

  8. Change from baseline in CAT (COPD Assessment test) total score at each time point

    Time frame: up to week 48

  9. 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

  10. Incidence and severity of adverse events

    Time frame: Up to week 50

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06035393
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Jan 15, 2024
Primary completion
Feb 17, 2025
Completion
Feb 17, 2025
Last update
Dec 22, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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