COPD PatientsPhase 2NCT07331402
A Clinical Study Evaluating the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients
A Phase 2 study testing HSK39004 inhalation suspension in people with COPD Patients, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a random, single blind, positive control, crossover design clinical study to evaluate the pharmacokinetics and pharmacodynamics of HSK39004 inhalation suspension in COPD patients Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD Patients
- What is being tested?
- HSK39004 inhalation suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2025to 30 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;
- COPD stable within 4 weeks prior to screening period (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 quit smoking for more than 6 months, or those with a history of exposure to other risk factors;
- Participants voluntarily sign the informed consent form；
Who cannot join
- Have a history of life-threatening COPD, including being admitted to the intensive care unit and/or requiring intubation;
- Have received treatment for COPD acute exacerbation for pneumonia within 12 weeks before screening;
- Have a history of or currently have severe cardiovascular diseases;
- 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;
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- 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;
- Allergy to HSK39004 inhalation powder or salbutamol or any known components in the administration system ; 8. Before the pulmonary function test during the screening (visit 1), any prohibited drugs in the protocol were used;
- During the screening period, there were clinically significant abnormalities in the 12 lead electrocardiogram that were determined by the researchers to be potentially risky for the subjects;
- 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;
- Pregnant or lactating women, or female subjects with positive pregnancy test results;
- Researchers determine other subjects who are not suitable to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
36 Sanhao Street, Heping District, Shenyang, Liaoning,China
Shenyang, Liaoning
About this study
Official title: A Random, Single Blind, Positive Control, Crossover Design Clinical Study to Evaluate the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients
This is a random, single blind, positive control, crossover design clinical study to evaluate the pharmacokinetics and pharmacodynamics of HSK39004 inhalation suspension in COPD patients
- Conditions
- COPD Patients
- Being tested
- HSK39004 inhalation suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK39004 inhalation suspensionDrug
Also called Ohtuvayre inhalation suspension
HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day
| Study group | Role | What they receive |
|---|---|---|
| HSK39004- Ohtuvayre | Experimental | The first period, HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; The second period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day Receives: Drug: HSK39004 inhalation suspension |
| Ohtuvayre - HSK39004 | Other | The first period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day; The second period，HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day. Receives: Drug: HSK39004 inhalation suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Cmax after single administrations
The Cmax of HSK39004 in plasma
Measured: [Time Frame: From the start of administration to 12 hours post-dose]
The Css(max) after multiple administrations (steady state)
The Css(max) of HSK39004 in plasma
Measured: [Time Frame: From the start of administration to 7 days post-dose]
Secondary outcomes (2)
The ΔFEV1 AUC0-12h
The area under the curve of FEV1 change from baseline from 0 to 12 hours after administration
Measured: [Time Frame: From the start of administration to 12 hours post-dose on Day1 and Day7]
AEs
The incidence and severity of AEs
Measured: [Time Frame: From the time of signing ICF to the end of follow-up，up to 7 days after the last administration]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start28 Jul 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD PatientsStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 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
- NCT07331402
- Sponsor's protocol ID
- HSK39004-201
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Random, Single Blind, Positive Control, Crossover Design Clinical Study to Evaluate the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients
- ClinicalTrials.gov ID
- NCT07331402
- Acronym / sponsor ID
- HSK39004-201
- Conditions
- COPD Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 9 Jan 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.
This is a random, single blind, positive control, crossover design clinical study to evaluate the pharmacokinetics and pharmacodynamics of HSK39004 inhalation suspension in COPD patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK39004- Ohtuvayre | Experimental | Drug: HSK39004 inhalation suspensionThe first period, HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; The second period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day |
| Ohtuvayre - HSK39004 | Other | Drug: HSK39004 inhalation suspensionThe first period，Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day; The second period，HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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):· FEV1/FVC after using bronchodilators is <0.7;· 30% of the expected value ≤ FEV1 after using bronchodilators < 80% of the expected value;
- COPD stable within 4 weeks prior to screening period (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 (12 listed)
- Have a history of life-threatening COPD, including being admitted to the intensive care unit and/or requiring intubation;
- Have received treatment for COPD acute exacerbation for pneumonia within 12 weeks before screening;
- Have a history of or currently have severe cardiovascular diseases;
- 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);
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 suspensionAlso: Ohtuvayre inhalation suspensionHSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day | Drug | HSK39004- Ohtuvayre, Ohtuvayre - HSK39004 |
Primary outcome
The Cmax after single administrations
Time frame: [Time Frame: From the start of administration to 12 hours post-dose]
The Cmax of HSK39004 in plasma
The Css(max) after multiple administrations (steady state)
Time frame: [Time Frame: From the start of administration to 7 days post-dose]
The Css(max) of HSK39004 in plasma
2 secondary outcomes
The ΔFEV1 AUC0-12h
Time frame: [Time Frame: From the start of administration to 12 hours post-dose on Day1 and Day7]
AEs
Time frame: [Time Frame: From the time of signing ICF to the end of follow-up，up to 7 days after the last administration]
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 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 inhalation suspension in people with COPD Patients, 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 7 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cmax after single administrations (time frame: [Time Frame: From the start of administration to 12 hours post-dose]). The study lists 2 primary outcomes in all. 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 Jan 2026.