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

Who can take part

• 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

Who cannot take part

• 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 lung volume reduction surgery within the 12 months prior to Screening
• Subjects receiving oxygen therapy required for greater than 15 hours a day
• 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)
• 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 who have Other known serious medical conditions；
• Suspected allergy to any ingredient in the study drug
• History of drug abuse within one year before screening
• Other conditions judged by the investigator to be not suitable to participate in the trial
• Subjects with significant laboratory abnormality at screening；
• Clinically significant electrocardiogram abnormality；
• Pregnant or lactating females