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

NCT06035393 | Terminated Phase 2

• 1 other identifier: HRG2005-201
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Up to week 12

Secondary Outcomes (10)

• 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

Study Arms (4)

Treatment group A

EXPERIMENTAL

Drug1 dose 1+Drug 3

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

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

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

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

Interventions

HRG2005 inhalation DRUG

Drug 1: dose 1; dose 2; dose 3

Treatment group A; Treatment group B; Treatment group C

Placebo to match HRG2005 inhalation DRUG

Drug 2

Treatment group B; Treatment group C; Treatment group D

Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation DRUG

Drug 3

Treatment group A; Treatment group B; Treatment group C

Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation DRUG

Drug 4

Treatment group D

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double blind, double dummy, active-controlled, parallel-group study.

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 13, 2023
• Study Start: January 15, 2024
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CN (1)