A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD

NCT07658339 | Not Yet Recruiting Phase 3

• 1 other identifier: HSK39004-301
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of HSK39004 Inhalation Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

PDE3/4

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12

  Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing.

  Baseline (pre-dose on Day 1) and Week 12

Secondary Outcomes (5)

• Change from Baseline in peak FEV1 within 4 hours after administration at week 4, 8, 12, 18, 24

  Baseline (pre-dose on Day 1) and Week 4, 8, 12, 18, 24

• Change from Baseline in Morning trough FEV1 after administration at week 4, 8, 12, 18, 24

  Baseline (pre-dose on Day 1) and week 4, 8, 12, 18, 24

• Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-4h) at Week 4, 8, 12, 18, 24

  Baseline (pre-dose on Day 1) and Week 4, 8, 12, 18, 24

• Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 12 and 24

  Day1, Weeks 12 and 24

• Treatment-emergent adverse event (TEAE) incidence

  From week 1 to week 25

Study Arms (2)

HSK39004 Inhalation Suspension

EXPERIMENTAL

3 mg BID

Drug: HSK39004 Inhalation Suspension

Placebo control

PLACEBO COMPARATOR

BID

Drug: Placebo control

Interventions

HSK39004 Inhalation Suspension DRUG

Dosage Formulation: HSK39004 Inhalation suspension Dosage 3mg，Twice Daily for 24 weeks

HSK39004 Inhalation Suspension

Placebo control DRUG

Dosage Formulation: Placebo Inhalation suspension Dosage 0mg，Twice Daily for 24 weeks

Placebo control

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• Known hypersensitivity to HSK39004 inhalation suspension, salbutamol, or any component of the drug delivery system;
• History of life-threatening acute exacerbation of COPD;
• Acute exacerbation of COPD (excluding the use of short-acting bronchodilators alone) or hospitalization for pneumonia within 12 weeks prior to screening (Visit 1);
• Acute (viral or bacterial) upper or lower respiratory tract infection within 6 weeks prior to screening (Visit 1);
• Diagnosis of any other clinically significant respiratory disease besides COPD, including but not limited to: alpha-1 antitrypsin deficiency, bronchial asthma, active tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, bronchiolitis obliterans, pulmonary sarcoidosis, or clinically significant idiopathic pulmonary fibrosis, pulmonary arterial hypertension, bronchiectasis (except asymptomatic localized bronchiectasis) that, in the opinion of the investigator, poses a safety risk to the participant or may affect the analysis of study result;
• Severe or uncontrolled cardiovascular disease or history;
• 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;
• History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;
• 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)

Peking University Third Hospital

Beijing, 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

Central Study Contacts

Yongchang Sun, Doctor

CONTACT

(+86)13910979132; suny@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 22, 2026
• Study Start: July 11, 2026
• Primary Completion (Estimated): June 11, 2027
• Study Completion (Estimated): June 11, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

CN (1)