Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Haisco Pharmaceutical Group Co., Ltd.
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;
2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and/ or a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) \<0.7\];
3. At screening visit (Visit 1):
Post-bronchodilator FEV1/FVC \< 0.7; and Post-bronchodilator FEV1 ≥ 30% and \< 80% of predicted value;
4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;
You may not be if
1. Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and/or before enrollment;
2. 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;
3. 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;
4. 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;
5. Known hypersensitivity to HSK39004 inhalation suspention, salbutamol, or any component of the drug delivery system;
6. Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1);
7. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;
8. Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion;
9. Subjects determined by the investigator to require oxygen therapy;
