Long-term safety of inhaled HSK39004 in people with chronic obstructive pulmonary disease
Tests inhaled HSK39004 over 52 weeks in adults with stable chronic obstructive pulmonary disease.
Plain-language title generated from the registry record
Registry title: Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD
Key facts
- Where
- Nanchang, ChinaSee the site
- Phase
- Phase 3
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: NCT07634367, who can take part
Where in China
- Jiangxi Provincial People's HospitalNanchang, ChinaNo longer taking part
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
- Haisco Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07634367
- Record updated
- 8 June 2026
- Original description
This clinical trial evaluates the long-term safety and efficacy of 3 mg HSK39004 Inhalation Suspension administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD).Read full original descriptionShow less
A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This clinical trial evaluates the long-term safety and efficacy of 3 mg HSK39004 Inhalation Suspension administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD).
Inclusion: 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female; Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening [GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and/ or a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) <0.7]; At screening visit (Visit 1):; Post-bronchodilator FEV1/FVC < 0.7; and Post-bronchodilator FEV1 ≥ 30% and < 80% of predicted value; Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening.
Exclusion: Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and/or before enrollment; Severe or uncontrolled cardiovascular disease or history, including but not limited to: New York Heart Association (NYHA) functional class III/IV at screening; acute myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening; clinically significant arrhythmia requiring intervention or marked QTcF prolongation (male >450 ms, female >470 ms) within 3 months prior to screening; or unstable or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) at screening; Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases/abnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis; Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1); History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening; Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion; Subjects determined by the investigator to require oxygen therapy; History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm; Known hypersensitivity to HSK39004 inhalation suspention, salbutamol, or any component of the drug delivery system; Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV).