Status:
TERMINATED
A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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 obstructiv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06035393
Start Date
January 15 2024
End Date
February 17 2025
Last Update
December 22 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191