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New inhaled therapy targets mucus in asthma and COPD – but trial halted early

NCT ID NCT05292950

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 3 times

Summary

This early-phase trial tested an inhaled drug called ARO-MUC5AC in healthy volunteers and people with asthma or COPD. The goal was to see if it is safe and how it affects lung function by targeting mucus production. The study was terminated early, so we have less information than planned.

What this could mean

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

Active substance
ARO-MUC5AC inhalation solution
What this could lead to
If successful, this could point toward a new treatment to reduce mucus buildup and improve breathing in people with asthma or COPD.
What could go wrong
The trial was terminated early, so results are limited. It was also an early-phase study focused on safety, not yet proving effectiveness.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

78 people

The number who actually took part.

Started

Jun 2022

Finished

Nov 2024

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

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Normal pulmonary function tests at Screening (NHVs only) * Confirmed diagnosis of asthma or COPD based on source verifiable medical record (asthma and COPD patients only) * No abnormal finding of clinical relevance at Screening (NHVs only) * Stable dose of asthma controller medications for at least 28 days prior to Screening (asthma patients only) * Documented treatment with an inhaled corticosteroid and at least 1 additional maintenance asthma controller medication for at least 3 months prior to Screening (asthma patients only) * Non-smoking (NHVs and asthma patients) * Current smoker or ex-smoker with smoking history of ≥ 10 pack-years (COPD patients only) * All COPD treatments have been stable for at least one month prior to Screening (COPD patients only) * Able to produce an induced sputum sample at Screening * Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 90 days following the last dose of study drug * Willing to provide written informed consent and to comply with study requirements Exclusion Criteria: * Acute lower respiratory infection within 30 days prior to first dose and/or acute upper respiratory infection within 7 days prior to first dose * Positive COVID-19 test during Screening window * Any history of chronic pulmonary disease (NHVs only) * Any concomitant pulmonary disease in asthma or COPD patients that could interfere with the evaluation of the study drug or interpretation of patient safety or study results * Use of theophylline within 30 days prior to first dose * History of lung volume reduction surgery or pneumonectomy (COPD patients) * Need for chronic oxygen support at Screening * Clinically significant health concerns (other than asthma in asthma patients) * Human immunodeficiency virus (HIV) infection, seropositive for hepatitis B virus (HBV), seropositive for hepatitis C virus (HCV) * Uncontrolled hypertension * Unwilling to limit alcohol consumption to within moderate limits for the duration of the study * Use of illicit drugs * Use of an investigational agent or device within 30 days prior to first dose Note: additional inclusion/exclusion criteria may apply per protocol

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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.

Contacts and locations

Locations

  • Research Site 1

    Nedlands, 6009, Australia

  • Research Site 1

    Auckland, 1010, New Zealand

  • Research Site 1

    Bialystok, 15-010, Poland

  • Research Site 1

    Seoul, 04763, South Korea

  • Research Site 1

    Barcelona, 08017, Spain

  • Research Site 1

    Bangkok, 10700, Thailand

  • Research Site 1

    Wythenshawe, Manchester, M23 9QZ, United Kingdom

  • Research Site 2

    South Brisbane, Queensland, 4101, Australia

  • Research Site 2

    Auckland, 1051, New Zealand

  • Research Site 2

    Krakow, 31-455, Poland

  • Research Site 2

    Jeonju, 54907, South Korea

  • Research Site 3

    Oświęcim, 32-600, Poland

  • Research Site 3

    Bucheon-si, Gyeonggi-do, 14647, South Korea

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