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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035393
• Other study ID #: HRG2005-201
• Status: Recruiting
• Phase: Phase 2
• Start date: January 15, 2024
• Est. completion date: August 28, 2025

Study information

• Verified date: January 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Xiaopeng Wang
• Phone: 0518-81220121
• Email: xiaopeng.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 28, 2025
• Est. primary completion date: August 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking.;

6. 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;

3. Subjects with other respiratory or respiratory related diseases, including but not limited to asthma, active tuberculosis, lung cancer, interstitial pulmonary disease, a1-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, drinking within one year before screening

13. Other conditions judged by the investigator to be not suitable to participate in the trial.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• HRG2005 inhalation
Drug 1: dose 1; dose 2; dose 3
• Placebo to match HRG2005 inhalation
Drug 2
• Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Drug 3
• Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Drug 4

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in morning pre-dose trough FEV1 at week 12		Up to week 12
Secondary	Change from baseline in morning pre-dose trough FEV1 at each time point		up to week 48
Secondary	Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point		up to week 48
Secondary	Proportion of subjects achieving an improvement from baseline=100mL in morning pre-dose trough FEV1		up to week 48
Secondary	Peak change from baseline in FEV1 at week 12		Up to week 12
Secondary	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
Secondary	Rate of moderate or severe COPD exacerbations over 48 Weeks		up to week 48
Secondary	Rate of severe COPD exacerbations over 48 Weeks		up to week 48
Secondary	Change from baseline in CAT (COPD Assessment test) total score at each time point		up to week 48
Secondary	Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point		up to week 48
Secondary	Incidence and severity of adverse events		Up to week 50