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New combo inhaler aims to stop asthma attacks faster

NCT ID NCT05555290

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 trial tested whether a combination inhaler containing albuterol and budesonide (PT027) works better than albuterol alone (PT007) for treating sudden asthma attacks. 190 adults with asthma who only used rescue inhalers as needed took part. Researchers measured lung function after triggering airway obstruction with mannitol. The goal was to see if the combo inhaler improves breathing more quickly or effectively.

What this could mean

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

Active substance
albuterol and budesonide combination inhaler
What this could lead to
If it works, this could offer a more effective rescue inhaler for asthma attacks by combining a bronchodilator with an anti-inflammatory.
What could go wrong
This is a completed Phase 3 trial, but results may not show a meaningful advantage over standard albuterol. The study used mannitol to trigger attacks, which may not reflect real-world asthma triggers.

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

190 people

The number who actually took part.

Started

Sep 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 130 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: * Participants who have been diagnosed with asthma \> 6 months before Visit 1 by a physician. * Participants must have been prescribed and using as-needed SABA as only asthma treatment for at least 4 weeks before screening visit. * Participants should have pre-bronchodilator FEV1 ≥ 1.5 L and FEV1 ≥ 60% to \< 90% predicted normal at Visit 1. * Participants should have a positive response to mannitol challenge performed at Visit 1 (a decrease in FEV1 by at least 15% \[PD15\] at ≤ 635 mg). * Participants should return to within 10% of baseline FEV1 (≥ 90% of baseline FEV1), within 1 hour after positive mannitol challenge and 4 inhalations of PT007, performed at Visit 1. * Participants should be able to adhere to study procedures in the judgment of the Investigator. * Male or female. * Women of childbearing potential must have a negative urine pregnancy test at each study visit. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. * Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Exclusion Criteria: * Any evidence of clinically significant lung disease other than asthma. * If the participant has had any face-to-face unscheduled or urgent visit for asthma worsening within the last 4 weeks. * Any significant disease or disorder, or evidence of drug/substance abuse which in the Investigator's opinion would pose a risk to participant safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the participant to participate in the study. * If participants have used Inhaled corticosteroids (ICS) within 1 month prior to enrolment. * If they have used immunosuppressive medication (including but not limited to methotrexate, troleandomycin, cyclosporine, azathioprine, systemic corticosteroids including regular treatment with oral corticosteroids or intramuscular long-acting depot corticosteroids, or any experimental anti-inflammatory therapy) within 3 months prior to enrolment (Visit 1) or plan on starting immunosuppressive medications during the study. * If they have used allergen-specific immunotherapy (desensitization) within 3 months prior to enrolment. * If they have used systemic corticosteroids (including oral and injected) within 3 months prior to enrolment. * If they have received any marketed or investigational biologic within 4 months or 5 half-lives prior to enrolment (whichever is longer) or received any investigational nonbiologic agent within 30 days or 5 half-lives prior to enrolment (whichever is longer). * Participants with a known hypersensitivity to beta2-agonists, ICS, mannitol, or any of the excipients of the product. * Any clinically significant abnormal findings in physical examination, vital signs, ECG (eg, participants with QTcF \> 500 ms), hematology, clinical chemistry, or urinalysis, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete entire duration of the study. * If they are current smokers or participants with smoking history ≥ 10 pack years including the use of vaping products, such as electronic cigarettes, and water pipes. If they are former smokers with a smoking history of \<10 pack years, including former vaping or water pipe users, smoking must have stopped for at least 6 months prior to Visit 1 to be eligible. * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and its affiliates and/or staff at the study site and their immediate relative(s)). * Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. * Breast feeding, pregnancy or intention to become pregnant during the course of the study. * Previous randomization in the present study.

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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

    Columbia, Maryland, 21046, United States

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