Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD

Official title

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)

Overview

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).

Interventions

• Drug HSK39004 Inhalation Suspension
  Dosage Formulation: HSK39004 Inhalation suspension Dosage 3mg; Twice Daily for 52 weeks

Primary outcome measures

• Treatment-emergent adverse event (TEAE) incidence [Time frame: From week 1 to week 53]

Eligibility criteria

Inclusion criteria

• 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 suspention, 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

• Jiangxi Provincial People's Hospital — Nanchang

Identifiers

NCT: NCT07634367 · HSK39004-302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗