A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Ki vehet részt

• Age ≥ 40 years old and < 80 years old, male or female
• Meet the weight standard
• Smoking history ≥ 10 pack-years
• COPD has been diagnosed ≥ 1 year
• 4 weeks before screening, the background treatment for COPD was stable
• FEV1/FVC < 0.7, 30% ≤ FEV1 ≤ 80%
• mMRC score ≥ 2
• The inspection and medication can be completed as required
• Non-pregnant and breastfeeding state
• Able and willing to provide a written informed consent

Ki nem vehet részt

• Concurrent diseases other than COPD that may affect lung function
• Lung resection, surgical lung volume reduction or endoscopic treatment for COPD
• Undergone major surgery or planned surgery within 14 months
• Requires oxygen inhalation or intermittent oxygen inhalation therapy
• Vaccination, theophylline or drugs within 4 weeks
• Having participated in other clinical studies within 4 weeks and used research drugs or medical devices containing active ingredients, or still within 5 half-lives of the research drug
• Overly potent/moderately potent drugs that inhibit or induce the liver drug-metabolizing enzyme CYP3A4 within 14 days
• Drug abuse and alcohol abuse within 1 year
• History of life-threatening COPD
• Other pulmonary diseases that may affect the efficacy evaluation of this study
• History of asthma
• Pulmonary heart disease requiring clinical intervention, or moderate to severe pulmonary hypertension
• Malignant tumors within 5 years
• Uncontrolled severe cardiovascular and cerebrovascular diseases within 1 year
• Unstable diseases
• Infection in the lungs or other parts occurs within 16 weeks and requires treatment
• Uncontrolled hypertension
• Tuberculosis infection requiring treatment within 16 to 12 months
• Biological agents that may have therapeutic effects on the studied disease have been used within 12 weeks or within 5 half-lives of the drug
• Allergic to the research drug or salbutamol or excipients
• Laboratory blood tests and electrocardiograms were significantly abnormal
• Acute exacerbation of COPD within 12 weeks, hospitalization for COPD or pneumonia within 6 months
• Immunosuppression
• Abnormal chest images have clinical significance
• Virological test result was positive
• Hypercapnia, using or requiring long-term use of any non-invasive positive pressure ventilation device
• Systemic glucocorticoids, immunosuppressants, and oral Roflumilast within 12 weeks
• Undergoing or planning rehabilitation treatment for pulmonary rehabilitation
• Non-selective β blockers within 1 week
• Has been used HRS-9821
• Pregnant or lactating period or planning to be pregnant or lactating
• The researchers judged that there were other unsuitable circumstances