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Tests treatment safety and results for Chronic Obstructive Lung Disease (COLD)
Official title Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT07140328
What this study is testing
What is HSK39004 Dry Powder Inhaler -0.75mg BID?
HSK39004 Dry Powder Inhaler -0.75mg BID is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic obstructive lung disease (cold).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and efficacy of the HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension compared with the placebo in the treatment of Chinese patients with COPD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;
- The people with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were...
- During the screening visit (Visit 1):
- FEV1/FVC after using bronchodilators is \<0.7;
- 30% of the expected value ≤ FEV1 after using bronchodilators \< 80% of the expected value; Note: Using bronchodilators refers to using 400 μg (4...
You likely can't join if
- Have received treatment for COPD acute exacerbation or been hospitalized for pneumonia within 12 weeks before screening;
- Have had acute (viral or bacterial) upper or lower respiratory tract infections or other infectious diseases requiring antibiotic treatment within 6...
- Have other diagnosed respiratory system diseases other than COPD, including but not limited to: α-1 antitrypsin deficiency, asthma, active...
- Have a history of or currently have severe cardiovascular diseases, including but not limited to:
- Screening period NYHA cardiac function grade III/IV (according to the NYHA cardiac function grading standard, see Appendix 1);
- Had acute myocardial infarction, unstable angina pectoris/acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass...
See the full eligibility criteria
- During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;
- The people with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year [GOLD 2025 standard: the people have...
- During the screening visit (Visit 1):
- FEV1/FVC after using bronchodilators is \<0.7;
- 30% of the expected value ≤ FEV1 after using bronchodilators \< 80% of the expected value; Note: Using bronchodilators refers to using 400 μg (4 puffs, 100 μg per puff, with an interval of 1 minute between each puff)...
- Clinically stable COPD in the 4 weeks prior to screening (Visit 1);
- During the screening period and treatment period, COPD drugs prohibited by the protocol (except for salbutamol inhalation aerosol as a rescue drug) can be discontinued;
- Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or former smokers (for example: at least 1 pack per...
- Have received treatment for COPD acute exacerbation or been hospitalized for pneumonia within 12 weeks before screening;
- Have had acute (viral or bacterial) upper or lower respiratory tract infections or other infectious diseases requiring antibiotic treatment within 6 weeks before screening;
- Have other diagnosed respiratory system diseases other than COPD, including but not limited to: α-1 antitrypsin deficiency, asthma, active tuberculosis, lung edema, cystic fibrosis, bronchiectasis, pulmonary nodular...
- Have a history of or currently have severe cardiovascular diseases, including but not limited to:
- Screening period NYHA cardiac function grade III/IV (according to the NYHA cardiac function grading standard, see Appendix 1);
- Had acute myocardial infarction, unstable angina pectoris/acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening;
- Structural heart disease, such as hypertrophic cardiomyopathy, moderate to severe valvular disease;
- Had severe arrhythmia within 3 months before screening, such as: atrial fibrillation with a ventricular rate \> 120 bpm, ventricular tachycardia, bradycardia (ventricular rate \ 450 ms or female QTcF \> 470 ms;
- people with poor blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at the screening visit);
- Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol/L at screening);
- Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for people with suspected malignant tumors or undetermined tumors);
- Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease/abnormal...
- During the screening period (visit 1), the investigator determines that the laboratory tests of the people show clinically significant abnormalities that may pose risks to the people, including but not limited to the...
- The glomerular filtration rate (eGFR) calculated using the CKD-EPI formula is less than 60 mL/min/1.73m2;
- Liver function: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) are more than 2.5 times the upper limit of the normal value; Total bilirubin (TBIL) is more than 1.5 times the upper limit of the...
- Lactose/milk protein (dairy products) intolerance, allergy to HSK39004 or salbutamol or any known components in the administration system;
- Before the pulmonary function test during the screening (visit 1), any prohibited drugs in the protocol were used (see Table 4 and Table 5 of the prohibited drug list in Section 5.9.3);
- Within 12 months before screening, received lobectomy or lung volume reduction surgery;
- Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study;
- Patients determined by the investigator to require oxygen therapy;
- Have clinically significant apnea that requires the use of a continuous airway positive pressure ventilation (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device;
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.