New inhaled therapy aims to improve breathing in COPD patients
NCT ID NCT07658339
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 study tests whether an inhaled medication called HSK39004 can improve lung function in people with moderate to severe chronic obstructive pulmonary disease (COPD). Participants receive either the drug or a placebo twice daily for 24 weeks. The main goal is to measure changes in how much air they can exhale in one second over a 12-hour period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK39004 inhalation suspension
- What this could lead to
- If successful, this could provide a new inhaled treatment option to help people with COPD breathe more easily and maintain better lung function.
- What could go wrong
- This is a phase 3 trial, but results may not show meaningful improvement over placebo. Side effects or lack of long-term benefit are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 387 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
Beijing, China
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