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New inhaled therapy aims to improve breathing in COPD patients

NCT ID NCT07658339

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 387 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

40 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking University Third Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.