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New combo inhaler aims to cut severe asthma attacks in half

NCT ID NCT06471257

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 4 times

Summary

This phase 3 study tests whether an inhaler combining budesonide (a steroid) and albuterol (a rescue drug) works better than albuterol alone for preventing severe asthma attacks. About 790 Chinese adults with asthma who have had at least one severe attack in the past year will use the inhaler as needed for 24 to 52 weeks. The main goal is to see if the combo inhaler delays the first severe attack.

What this could mean

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

Active substance
Budesonide/Albuterol inhaler (PT027)
What this could lead to
If successful, this could provide a more effective as-needed treatment for asthma that reduces the risk of severe attacks compared to using albuterol alone.
What could go wrong
This is a phase 3 trial, but results may not apply to all asthma patients. The study only includes Chinese adults, and the benefit over standard care may be modest. Side effects from the added steroid 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 1,000 people

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

Started

Jun 2024

Expected to finish

Oct 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

18 years and older

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. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 2. Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1 3. Pre-bronchodilator FEV1 of ≥ 40% to \< 90% predicted normal value for adults. 4. Documented reversibility to albuterol 5. A documented history of at least one severe asthma exacerbation within 12 months before Visit 1 6. ACQ-7 score ≥ 1.5 assessed at Visit 1 7. ACQ-5 score ≥ 1.5 assessed at Visit 2 8. Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months 9. Use of Sponsor-provided salbutamol sulfate inhalation aerosol as needed medication due to asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2 10. Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited 11. Able to perform acceptable and reproducible PEF measurements as assessed by the investigator 12. BMI \< 40 kg/m2 13. Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential 14. Women of childbearing potential must agree to prevent pregnancy 15. Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments Exclusion Criteria: 1. Chronic obstructive pulmonary disease or other significant lung disease 2. Oral/SCS use (any dose) within 6 weeks before Visit 1 3. Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1 4. Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication 5. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months before Visit 1 6. Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within last 5 years of Visit 1 7. Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1 8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1 9. Clinically significant laboratory abnormalities 10. Historical or current evidence of a clinically significant disease 11. Cancer not in complete remission for at least 5 years before Visit 1 12. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity 13. Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients 14. Inability to abstain from protocol-defined prohibited medications during the study 15. Having received a live attenuated vaccination within 7 days of Visit 1 16. Currently pregnant or breastfeeding 17. Participants who experience \> 1 asthma exacerbation during the screening period

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    83 sites. 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

  • Research Site

    RECRUITING

    Baotou, 014010, China

  • Research Site

    RECRUITING

    Baotou, 14010, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Beijing, 100020, China

  • Research Site

    RECRUITING

    Beijing, 100029, China

  • Research Site

    RECRUITING

    Beijing, 100039, China

  • Research Site

    RECRUITING

    Beijing, 100191, China

  • Research Site

    RECRUITING

    Changchun, 130021, China

  • Research Site

    RECRUITING

    Changchun, 130041, China

  • Research Site

    RECRUITING

    Changsha, 410005, China

  • Research Site

    RECRUITING

    Changsha, 410015, China

  • Research Site

    RECRUITING

    Chengdu, 610000, China

  • Research Site

    RECRUITING

    Chengdu, 610021, China

  • Research Site

    RECRUITING

    Chengdu, 610041, China

  • Research Site

    RECRUITING

    Chengdu, 610072, China

  • Research Site

    RECRUITING

    Chengdu, 610500, China

  • Research Site

    RECRUITING

    Chizhou, 247099, China

  • Research Site

    RECRUITING

    Chongqing, 400010, China

  • Research Site

    RECRUITING

    Chongqing, 400037, China

  • Research Site

    COMPLETED

    Chongqing, 401320, China

  • Research Site

    RECRUITING

    Dazhou, 635000, China

  • Research Site

    RECRUITING

    Deyang, 618000, China

  • Research Site

    RECRUITING

    Ganzhou, 341099, China

  • Research Site

    RECRUITING

    Guangyuan, 628000, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Guangzhou, 510000, China

  • Research Site

    RECRUITING

    Guangzhou, 510080, China

  • Research Site

    COMPLETED

    Guangzhou, 510080, China

  • Research Site

    RECRUITING

    Guangzhou, 510145, China

  • Research Site

    RECRUITING

    Guangzhou, 510163, China

  • Research Site

    RECRUITING

    Guangzhou, 510317, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Haikou, 570208, China

  • Research Site

    RECRUITING

    Hangzhou, 310006, China

  • Research Site

    WITHDRAWN

    Hangzhou, 310009, China

  • Research Site

    RECRUITING

    Hefei, 133500, China

  • Research Site

    RECRUITING

    Hefei, 230061, China

  • Research Site

    RECRUITING

    Hefei, 230601, China

  • Research Site

    WITHDRAWN

    Heifei, 230011, China

  • Research Site

    RECRUITING

    Hohhot, 010017, China

  • Research Site

    RECRUITING

    Hohhot, 010050, China

  • Research Site

    RECRUITING

    Huizhou, 516001, China

  • Research Site

    RECRUITING

    Huizhou, 516002, China

  • Research Site

    RECRUITING

    Jinan, 250001, China

  • Research Site

    RECRUITING

    Jinhua, China

  • Research Site

    RECRUITING

    Jining, 272029, China

  • Research Site

    RECRUITING

    Kunming, 650032, China

  • Research Site

    RECRUITING

    Lanzhou, 730000, China

  • Research Site

    RECRUITING

    Linhai, 317000, China

  • Research Site

    RECRUITING

    Luoyang, 471000, China

  • Research Site

    RECRUITING

    Luzhou, 646000, China

  • Research Site

    WITHDRAWN

    Luzhou, 646000, China

  • Research Site

    RECRUITING

    Mianyang, 621000, China

  • Research Site

    RECRUITING

    Nanchang, 330006, China

  • Research Site

    RECRUITING

    Nanchong, 637000, China

  • Research Site

    RECRUITING

    Nanjing, 210009, China

  • Research Site

    RECRUITING

    Nanjing, 210012, China

  • Research Site

    WITHDRAWN

    Nantong, 226001, China

  • Research Site

    WITHDRAWN

    Ningbo, 315010, China

  • Research Site

    WITHDRAWN

    Panjin, 124009, China

  • Research Site

    RECRUITING

    Panzhihua, 617099, China

  • Research Site

    RECRUITING

    Pingxiang, 337055, China

  • Research Site

    RECRUITING

    Qingdao, 266011, China

  • Research Site

    RECRUITING

    Rui’an, 325200, China

  • Research Site

    WITHDRAWN

    Sanya, 572000, China

  • Research Site

    RECRUITING

    Shanghai, 200032, China

  • Research Site

    COMPLETED

    Shanghai, 200080, China

  • Research Site

    RECRUITING

    Shanghai, 201199, China

  • Research Site

    RECRUITING

    Shenyang, 110004, China

  • Research Site

    RECRUITING

    Shenyang, 110032, China

  • Research Site

    RECRUITING

    Shenzhen, 518020, China

  • Research Site

    RECRUITING

    Shenzhen, 518036, China

  • Research Site

    RECRUITING

    Shijiazhuang, 054001, China

  • Research Site

    RECRUITING

    Shijiazhuang, 50051, China

  • Research Site

    RECRUITING

    Suining, 629000, China

  • Research Site

    RECRUITING

    Taiyuan, 030001, China

  • Research Site

    RECRUITING

    Taiyuan, 030032, China

  • Research Site

    RECRUITING

    Tianjin, 300050, China

  • Research Site

    RECRUITING

    Ürümqi, 830054, China

  • Research Site

    RECRUITING

    Wenzhou, 325000, China

  • Research Site

    RECRUITING

    Wenzhou, 325027, China

  • Research Site

    RECRUITING

    Wuhan, 430030, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Wuhan, 430060, China

  • Research Site

    WITHDRAWN

    Wuhu, 241000, China

  • Research Site

    RECRUITING

    Xi'an, 710006, China

  • Research Site

    RECRUITING

    Xiamen, 361003, China

  • Research Site

    RECRUITING

    Xintai, 54031, China

  • Research Site

    RECRUITING

    Xinxiang, 453002, China

  • Research Site

    RECRUITING

    Xuzhou, 221000, China

  • Research Site

    RECRUITING

    Xuzhou, 221009, China

  • Research Site

    RECRUITING

    Yangzhou, 225003, China

  • Research Site

    RECRUITING

    Yibin, 610500, China

  • Research Site

    RECRUITING

    Yinchuan, 750001, China

  • Research Site

    COMPLETED

    Yinchuan, 750004, China

  • Research Site

    WITHDRAWN

    Yueyang, 414000, China

  • Research Site

    RECRUITING

    Yuhuan, 317600, China

  • Research Site

    RECRUITING

    Zhangzhou, 363000, China

  • Research Site

    RECRUITING

    Zhengzhou, 450003, China

  • Research Site

    RECRUITING

    Zhengzhou, 450052, China

  • Research Site

    RECRUITING

    Zhuhai, 519000, China

  • Research Site

    RECRUITING

    Zhuji, 311899, China

  • Research Site

    RECRUITING

    Zibo, 255036, China

  • Research Site

    WITHDRAWN

    Zigong, 643000, China

  • Research Site

    RECRUITING

    Zunyi, 563100, China

  • Research Site

    ACTIVE_NOT_RECRUITING

    Hong Kong, 999077, Hong Kong

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