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New inhaler hope for COPD patients in early trial

NCT ID NCT07640451

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 19, 2026 · Updated 4 times

Summary

This study tests a new inhaled drug called HRS-9821 in people with moderate to severe COPD. About 90 participants will receive either the drug or a placebo for 28 days. The main goal is to see if the drug improves lung function, measured by how much air they can exhale in one second.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS-9821 inhalation suspension
What this could lead to
If successful, this could lead to a new inhaled treatment option for people with moderate to severe COPD, potentially improving their lung function and daily breathing.
What could go wrong
This is an early Phase 2 trial with only 90 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

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

Started

Jul 2026

Expected to finish

Nov 2026

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.

Inclusion Criteria: 1. Age ≥ 40 years old and \< 80 years old, male or female. 2. Meet the weight standard. 3. Smoking history ≥ 10 pack-years. 4. COPD has been diagnosed ≥ 1 year. 5. 4 weeks before screening, the background treatment for COPD was stable. 6. FEV1/FVC \< 0.7, 30% ≤ FEV1 ≤ 80%. 7. mMRC score ≥ 2. 8. The inspection and medication can be completed as required. 9. Non-pregnant and breastfeeding state. 10. Able and willing to provide a written informed consent. Exclusion Criteria: 1. History of life-threatening COPD. 2. Other pulmonary diseases that may affect the efficacy evaluation of this study. 3. Concurrent diseases other than COPD that may affect lung function. 4. History of asthma. 5. Pulmonary heart disease requiring clinical intervention, or moderate to severe pulmonary hypertension. 6. Malignant tumors within 5 years. 7. Uncontrolled severe cardiovascular and cerebrovascular diseases within 1 year. 8. Unstable diseases. 9. Acute exacerbation of COPD within 12 weeks, hospitalization for COPD or pneumonia within 6 months. 10. Infection in the lungs or other parts occurs within 16 weeks and requires treatment. 11. Immunosuppression. 12. Uncontrolled hypertension. 13. Lung resection, surgical lung volume reduction or endoscopic treatment for COPD. 14. Undergone major surgery or planned surgery within 14 months. 15. Abnormal chest images have clinical significance. 16. Tuberculosis infection requiring treatment within 16 to 12 months. 17. Virological test result was positive. 18. Laboratory blood tests and electrocardiograms were significantly abnormal. 19. Requires oxygen inhalation or intermittent oxygen inhalation therapy. 20. Hypercapnia, using or requiring long-term use of any non-invasive positive pressure ventilation device. 21. Biological agents that may have therapeutic effects on the studied disease have been used within 12 weeks or within 5 half-lives of the drug. 22. Vaccination, theophylline or drugs within 4 weeks. 23. Having participated in other clinical studies within 4 weeks and used research drugs or medical devices containing active ingredients, or still within 5 half-lives of the research drug. 24. Systemic glucocorticoids, immunosuppressants, and oral Roflumilast within 12 weeks. 25. Undergoing or planning rehabilitation treatment for pulmonary rehabilitation. 26. Non-selective β blockers within 1 week. 27. Overly potent/moderately potent drugs that inhibit or induce the liver drug-metabolizing enzyme CYP3A4 within 14 days. 28. Allergic to the research drug or salbutamol or excipients. 29. Has been used HRS-9821. 30. Drug abuse and alcohol abuse within 1 year. 31. Pregnant or lactating period or planning to be pregnant or lactating. 32. The researchers judged that there were other unsuitable circumstances.

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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

  • Shanghai Tongji Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200065, China

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