Chronic Obstructive Lung Disease (COLD)Phase 2NCT07140328
Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing HSK39004 Dry Powder Inhaler -0.75mg BID, HSK39004 Dry Powder Inhaler -1.5mg BID and HSK39004 Inhalation Suspension -3mg BID in people with Chronic Obstructive Lung Disease (COLD), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Lung Disease (COLD)
- What is being tested?
- HSK39004 Dry Powder Inhaler -0.75mg BID, HSK39004 Dry Powder Inhaler -1.5mg BID and HSK39004 Inhalation Suspension -3mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2025to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;
- The subjects 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 subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) <0.7];
- 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) salbutamol inhalation aerosol for 15 to 30 minutes after use.
- 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 day, for 10 years), or those with a history of exposure to other risk factors.
Who cannot join
- 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 disease, or clinically significant pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, bronchiectasis (excluding asymptomatic local bronchial dilation);
- 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;
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- 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 < 45 bpm), second-degree II or above atrioventricular conduction block (excluding those with implanted pacemaker or defibrillator), male QTcF > 450 ms or female QTcF > 470 ms;
- Subjects 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 subjects 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 history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results;
- During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects, including but not limited to the following situations:
- 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 normal value.
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial People's Hospital
Nanchang, Jiangsu
Min Jiang, +86130 3720 0789, jmjxnc@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
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.
- Conditions
- Chronic Obstructive Lung Disease (COLD)
- Being tested
- HSK39004 Dry Powder Inhaler -0.75mg BID, HSK39004 Dry Powder Inhaler -1.5mg BID, HSK39004 Inhalation Suspension -3mg BID, HSK39004 Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK39004 Dry Powder Inhaler -0.75mg BIDDrug
HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
HSK39004 Dry Powder Inhaler -1.5mg BIDDrug
HSK39004 Dry Powder Inhaler: Inhale through the mouth, 1.5mg each time, twice a day； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
HSK39004 Inhalation Suspension -3mg BIDDrug
HSK39004 Inhalation Suspension: Inhale through the mouth, 3mg each time, twice a day； And HSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ；
HSK39004 PlaceboDrug
HSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ；
| Study group | Role | What they receive |
|---|---|---|
| HSK39004 Dry Powder Inhaler -0.75mg BID | Experimental | HSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day； Receives: Drug: HSK39004 Dry Powder Inhaler -0.75mg BID |
| HSK39004 Dry Powder Inhaler -1.5mg BID | Experimental | HSK39004 Dry Powder Inhaler: Inhale through the mouth, 1.5mg each time, twice a day； Receives: Drug: HSK39004 Dry Powder Inhaler -1.5mg BID |
| HSK39004 Inhalation Suspension -3mg BID | Experimental | HSK39004 Inhalation Suspension: Inhale through the mouth, 3mg each time, twice a day； Receives: Drug: HSK39004 Inhalation Suspension -3mg BID |
| HSK39004 Placebo | Placebo comparator | HSK39004 Dry Powder Inhaler Simulants and HSK39004 Inhalation Suspension Simulants Receives: Drug: HSK39004 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The ΔFEV1 AUC0-12h after the 4th week administration (the area under the curve representing the change in FEV1 from baseline to 12 hours after administration)
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start24 Apr 2025
- Primary completion10 Jul 2025
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung Disease (COLD)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140328
- Sponsor's protocol ID
- HSK39004-T1-201
- Status last verified
- Apr 2026
- First submitted
- 18 Aug 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07140328
- Acronym / sponsor ID
- HSK39004-T1-201
- Conditions
- Chronic Obstructive Lung Disease (COLD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSK39004 Dry Powder Inhaler -0.75mg BID | Experimental | Drug: HSK39004 Dry Powder Inhaler -0.75mg BIDHSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day； |
| HSK39004 Dry Powder Inhaler -1.5mg BID | Experimental | Drug: HSK39004 Dry Powder Inhaler -1.5mg BIDHSK39004 Dry Powder Inhaler: Inhale through the mouth, 1.5mg each time, twice a day； |
| HSK39004 Inhalation Suspension -3mg BID | Experimental | Drug: HSK39004 Inhalation Suspension -3mg BIDHSK39004 Inhalation Suspension: Inhale through the mouth, 3mg each time, twice a day； |
| HSK39004 Placebo | Placebo comparator | Drug: HSK39004 PlaceboHSK39004 Dry Powder Inhaler Simulants and HSK39004 Inhalation Suspension Simulants |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;
- The subjects 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 subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) <0.7];
- During the screening visit (Visit 1):
- 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;
Key exclusion criteria (21 listed)
- 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 disease, or clinically significant pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, bronchiectasis (excluding asymptomatic local bronchial dilation);
- Have a history of or currently have severe cardiovascular diseases, including but not limited to:
- Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol/L at screening);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK39004 Dry Powder Inhaler -0.75mg BIDHSK39004 Dry Powder Inhaler: Inhale through the mouth, 0.75mg each time, twice a day； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ； | Drug | HSK39004 Dry Powder Inhaler -0.75mg BID |
| HSK39004 Dry Powder Inhaler -1.5mg BIDHSK39004 Dry Powder Inhaler: Inhale through the mouth, 1.5mg each time, twice a day； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ； | Drug | HSK39004 Dry Powder Inhaler -1.5mg BID |
| HSK39004 Inhalation Suspension -3mg BIDHSK39004 Inhalation Suspension: Inhale through the mouth, 3mg each time, twice a day； And HSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ； | Drug | HSK39004 Inhalation Suspension -3mg BID |
| HSK39004 PlaceboHSK39004 Dry Powder Inhaler Simulants,administered via oral inhalation, 1 tablet each time, twice daily ； And HSK39004 Inhalation Suspension Simulants,administered via oral inhalation, Two units each time, twice daily ； | Drug | HSK39004 Placebo |
Primary outcome
1. The ΔFEV1 AUC0-12h after the 4th week administration (the area under the curve representing the change in FEV1 from baseline to 12 hours after administration)
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK39004 Dry Powder Inhaler -0.75mg BID, HSK39004 Dry Powder Inhaler -1.5mg BID and HSK39004 Inhalation Suspension -3mg BID in people with Chronic Obstructive Lung Disease (COLD), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fangqiong Li (+8602867258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. The ΔFEV1 AUC0-12h after the 4th week administration (the area under the curve representing the change in FEV1 from baseline to 12 hours after administration) (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.