Assessing HRG2005 inhalation for COPD treatment

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 study is testing if a new inhaled treatment called HRG2005 can help people with moderate to severe COPD breathe better and feel healthier compared to a placebo and other existing medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06035393 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of HRG2005 inhalation in patients suffering from moderate to severe chronic obstructive pulmonary disease (COPD). It is a randomized, double-blind, double-dummy, active-controlled study involving approximately 200 participants. Patients will be assigned to receive either HRG2005 inhalation or a placebo, alongside a comparison with Indacaterol Maleate and Glycopyrronium Bromide. The study aims to determine how well HRG2005 can improve lung function and overall health in COPD patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a history of moderate to severe COPD and specific lung function criteria.

Not a fit: Patients with recent severe exacerbations or infections that required hospitalization may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with moderate to severe COPD.

How similar studies have performed: Other studies have shown promise with similar inhalation therapies for COPD, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xiaopeng Wang

Conditions Chronic Obstructive Pulmonary Disease