Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHaisco Pharmaceutical Group Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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];
Post-bronchodilator FEV1/FVC < 0.7; and
Post-bronchodilator FEV1 ≥ 30% and < 80% of predicted value;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
HSK39004 Dry Powder Inhaler -0.75mg BID
DrugHSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: HSK39004 Dry Powder Inhaler -0.75mg BIDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-emergent adverse event (TEAE) incidence
The incidence of treatment-emergent adverse events (TEAEs), assessed through vital signs, physical examinations, laboratory tests, 12-lead ECG parameters, and detailed adverse event monitoring.
Time frame
From week 1 to week 53Sponsors and contacts
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Source ClinicalTrials.gov
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