Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK39004 Dry Powder Inhaler -0.75mg BID.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Lung Disease (COLD). Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Overview
This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD), including both newly enrolled and those who have completed prior participation in the HSK39004-201, HSK39004-T1-201, or HSK39004-T1-202 studies as a long-term extension.
Interventions
- Drug HSK39004 Dry Powder Inhaler -0.75mg BID
HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day
Primary outcome measures
- Treatment-emergent adverse event (TEAE) incidence [Time frame: From week 1 to week 53]
Eligibility criteria
Inclusion criteria
- Aged 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 criteria
- 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;
- 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;
- 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;
- Known hypersensitivity to HSK39004 inhalation powder, salbutamol, or any component of the drug delivery system;
- 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;
- Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guizhou Provincial People's Hospital — Guiyang
Identifiers
NCT: NCT07425210 · HSK39004-T1-204