Not yet recruiting NCT07658339
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With 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 Inhalation Suspension, Placebo control.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). 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 Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Overview
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).
Interventions
- Drug HSK39004 Inhalation Suspension
Dosage Formulation: HSK39004 Inhalation suspension Dosage 3mg，Twice Daily for 24 weeks - Drug Placebo control
Dosage Formulation: Placebo Inhalation suspension Dosage 0mg，Twice Daily for 24 weeks
Primary outcome measures
- Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12 [Time frame: Baseline (pre-dose on Day 1) and Week 12]
Secondary outcome measures (5)
- Change from Baseline in peak FEV1 within 4 hours after administration at week 4, 8, 12, 18, 24 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Day1, Weeks 12 and 24]
- Treatment-emergent adverse event (TEAE) incidence [Time frame: From week 1 to week 25]
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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT07658339 · HSK39004-301