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

NCT07634367 | Not Yet Recruiting Phase 3

• 1 other identifier: HSK39004-302
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

PDE3/4

Outcome Measures

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.

  From week 1 to week 53

Study Arms (1)

HSK39004 Inhalation Suspension

EXPERIMENTAL

3mg BID

Drug: HSK39004 Inhalation Suspension

Interventions

HSK39004 Inhalation Suspension DRUG

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

HSK39004 Inhalation Suspension

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): December 24, 2027
• Study Completion (Estimated): December 24, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CN (1)