Tests HRS-9821 inhalation suspension in adults with moderate to severe COPD
Tests an inhaled medicine, HRS-9821, against a placebo in people with COPD.
Plain-language title generated from the registry record
Registry title: A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT07640451, who can take part
Where in China
- Shanghai Tongji HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Trial code
- NCT07640451
- Record updated
- 18 August 2026
- Original description
The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.
Inclusion: 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.
Exclusion: 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.