COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
PDE3/4
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).
Interventions
Dosage Formulation: HSK39004 Inhalation suspension Dosage 3mg，Twice Daily for 24 weeks
DRUGPlacebo control
Dosage Formulation: Placebo Inhalation suspension Dosage 0mg，Twice Daily for 24 weeks
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female; 2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and/or a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) \<0.7\]; 3. At screening visit (Visit 1): * Post-bronchodilator FEV1/FVC \< 0.7; and * Post-bronchodilator FEV1 ≥ 30% and \< 80% of predicted value; 4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening; Key
Exclusion criteria
1. Known hypersensitivity to HSK39004 inhalation suspension, salbutamol, or any component of the drug delivery system; 2. History of life-threatening acute exacerbation of COPD; 3. Acute exacerbation of COPD (excluding the use of short-acting bronchodilators alone) or hospitalization for pneumonia within 12 weeks prior to screening (Visit 1); 4. Acute (viral or bacterial) upper or lower respiratory tract infection within 6 weeks prior to screening (Visit 1); 5. 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; 6. Severe or uncontrolled cardiovascular disease or history; 7. 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; 8. 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; 9. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening; 10. Subjects determined by the investigator to require oxygen therapy; 11. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Average Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) at Week 12 | Baseline (pre-dose on Day 1) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Peak FEV1 is the maximum value in the 4 hours after dosing. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing. |
| 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 | Morning trough FEV1 was the last value collected prior to the morning dose. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing. |
| 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 | Average FEV1 AUC0-4h was defined as AUC over 4 hours of the FEV1, divided by 4 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing. |
| Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 12 and 24 | Day1, Weeks 12 and 24 | The SGRQ questionnaire consists of 17 questions, split into 2 parts. Part 1 consisted of the first 8 questions and was related to the symptoms subdomain. The remaining 9 questions were in Part 2, which were related to the activity and impacts subdomains. The total score was calculated by dividing the summed weights by the maximum possible weight for all items in the questionnaire and expressing the result as a percentage. Score ranging from 0 to 100 and higher scores indicated a worse outcome. Baseline is the score calculated on Day 1. |
| Treatment-emergent adverse event (TEAE) incidence | From week 1 to week 25 | 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. |
Countries
China
Contacts
CONTACTYongchang Sun, Doctor
Outcome results
None listed