COPD (Chronic Obstructive Pulmonary Disease)Phase 3NCT07658339
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD
A Phase 3 study testing HSK39004 Inhalation Suspension in people with COPD (Chronic Obstructive Pulmonary Disease), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- HSK39004 Inhalation Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2026to 11 Jun 2027
- Phase
- Phase 3
- 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
- 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;
Who cannot join
- 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;
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
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).
- Being tested
- HSK39004 Inhalation Suspension, Placebo control
- Keywords
- PDE3/4
- 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 Inhalation SuspensionDrug
Dosage Formulation: HSK39004 Inhalation suspension Dosage 3mg，Twice Daily for 24 weeks
Placebo controlDrug
Dosage Formulation: Placebo Inhalation suspension Dosage 0mg，Twice Daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| HSK39004 Inhalation Suspension | Experimental | 3 mg BID Receives: Drug: HSK39004 Inhalation Suspension |
| Placebo control | Placebo comparator | BID Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Day1, Weeks 12 and 24
Treatment-emergent adverse event (TEAE) incidence
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.
Measured: From week 1 to week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start11 Jul 2026 (estimated)
- Primary completion11 Jun 2027 (estimated)
- Study completion11 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 387 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
- NCT07658339
- Sponsor's protocol ID
- HSK39004-301
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07658339
- Acronym / sponsor ID
- HSK39004-301
- Keywords
- PDE3/4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 387 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2026 (estimated)
- Primary completion
- 11 Jun 2027 (estimated)
- Study completion
- 11 Jun 2027 (estimated)
- First posted
- 22 Jun 2026 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK39004 Inhalation Suspension | Experimental | Drug: HSK39004 Inhalation Suspension3 mg BID |
| Placebo control | Placebo comparator | Drug: Placebo controlBID |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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):
- Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;
Key exclusion criteria (11 listed)
- 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;
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 Inhalation SuspensionDosage Formulation: HSK39004 Inhalation suspension Dosage 3mg，Twice Daily for 24 weeks | Drug | HSK39004 Inhalation Suspension |
| Placebo controlDosage Formulation: Placebo Inhalation suspension Dosage 0mg，Twice Daily for 24 weeks | Drug | Placebo control |
Primary outcome
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
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.
5 secondary outcomes
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
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 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 3 study testing HSK39004 Inhalation Suspension in people with COPD (Chronic Obstructive Pulmonary Disease), 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 22 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yongchang Sun, Doctor ((+86)13910979132, suny@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 22 Jun 2026.