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

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06035393

HRG2005-201

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 4 patient groups

Treatment group A

Experimental group

Description:

Drug1 dose 1+Drug 3

Treatment:

Drug: HRG2005 inhalation

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

Treatment group B

Experimental group

Description:

Drug1 dose 2+Drug 2+Drug 3

Treatment:

Drug: Placebo to match HRG2005 inhalation

Drug: HRG2005 inhalation

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

Treatment group C

Experimental group

Description:

Drug1 dose 3+Drug 2+Drug 3

Treatment:

Drug: Placebo to match HRG2005 inhalation

Drug: HRG2005 inhalation

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

Treatment group D

Other group

Description:

Drug 2+Drug 4

Treatment:

Drug: Placebo to match HRG2005 inhalation

Drug: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation