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New inhaler combo aims to cut severe asthma Flare-Ups in teens

NCT ID NCT06307665

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests a new inhaler (PT027) against a standard one (PT007) in 440 teens aged 12 to 18 with asthma. The goal is to see if PT027 reduces the number of severe asthma attacks over a year. Participants must have had at least one severe attack in the past year and use daily asthma medication.

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 440 people

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

Started

May 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

12 to 17 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: * Confirmed clinical diagnosis of asthma at least 12 months. * Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month 1. Low-to-high-dose Inhaled corticosteroid(s) (ICS) 2. Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline * Receiving inhaled short-acting β2-agonist (SABA) as needed. * A documented history of at least one severe asthma exacerbation within 12 months. * Use of Sponsor-provided albuterol sulfate inhalation aerosol medication. * Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited. * Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator. * Participants must adhere to protocol specific contraception methods. * Negative urine pregnancy test for participants of childbearing potential. * Have a BMI \< 40 kg/ m\^2. * Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures. Exclusion Criteria: * Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). * Experienced \> 3 severe asthma exacerbations within 12 months before screening. * Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening. * Upper respiratory infection involving antibiotic treatment not resolved. * Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana). * Other significant lung disease, including regular or occasional use of oxygen. * Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders. * Cancer not in complete remission for at least 5 years. * History or hospitalization for psychiatric disorder or attempted suicide within one year. * Significant abuse of alcohol or drugs, in the opinion of the investigator. * Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1). * Use of any oral SABAs within one month. * Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.

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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

    131 sites in 4 countries. 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

    Anchorage, Alaska, 99508, United States

  • Research Site

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Research Site

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Research Site

    COMPLETED

    Little Rock, Arkansas, 72202, United States

  • Research Site

    NOT_YET_RECRUITING

    Huntington Beach, California, 92647, United States

  • Research Site

    NOT_YET_RECRUITING

    Huntington Beach, California, 92648, United States

  • Research Site

    RECRUITING

    Long Beach, California, 90806, United States

  • Research Site

    RECRUITING

    Long Beach, California, 90815, United States

  • Research Site

    NOT_YET_RECRUITING

    Madera, California, 93636, United States

  • Research Site

    RECRUITING

    Mission Viejo, California, 92691, United States

  • Research Site

    RECRUITING

    Moreno Valley, California, 92553, United States

  • Research Site

    RECRUITING

    Orange, California, 92868, United States

  • Research Site

    NOT_YET_RECRUITING

    Redondo Beach, California, 90277, United States

  • Research Site

    RECRUITING

    Riverside, California, 92506, United States

  • Research Site

    RECRUITING

    San Diego, California, 92123, United States

  • Research Site

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Research Site

    WITHDRAWN

    San Francisco, California, 94143, United States

  • Research Site

    RECRUITING

    Westminster, California, 92683, United States

  • Research Site

    RECRUITING

    Denver, Colorado, 80206, United States

  • Research Site

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Research Site

    RECRUITING

    Destin, Florida, 32541, United States

  • Research Site

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Research Site

    NOT_YET_RECRUITING

    Kendall, Florida, 33176, United States

  • Research Site

    COMPLETED

    Largo, Florida, 33777, United States

  • Research Site

    NOT_YET_RECRUITING

    Miami, Florida, 33142, United States

  • Research Site

    NOT_YET_RECRUITING

    Miami, Florida, 33144, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33145, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33185, United States

  • Research Site

    NOT_YET_RECRUITING

    Pembroke Pines, Florida, 33026, United States

  • Research Site

    WITHDRAWN

    Tampa, Florida, 33613, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Research Site

    RECRUITING

    Columbus, Georgia, 31904, United States

  • Research Site

    RECRUITING

    Fayetteville, Georgia, 30214, United States

  • Research Site

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Research Site

    WITHDRAWN

    Meridian, Idaho, 83646, United States

  • Research Site

    RECRUITING

    Normal, Illinois, 61761, United States

  • Research Site

    WITHDRAWN

    River Forest, Illinois, 60305, United States

  • Research Site

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Research Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Research Site

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Research Site

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40217, United States

  • Research Site

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Research Site

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Research Site

    RECRUITING

    New Orleans, Louisiana, 70125, United States

  • Research Site

    RECRUITING

    Ellicott City, Maryland, 21043, United States

  • Research Site

    NOT_YET_RECRUITING

    Lanham, Maryland, 20706, United States

  • Research Site

    RECRUITING

    Silver Spring, Maryland, 20902, United States

  • Research Site

    RECRUITING

    White Marsh, Maryland, 21162, United States

  • Research Site

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Research Site

    ACTIVE_NOT_RECRUITING

    Mankato, Minnesota, 56001, United States

  • Research Site

    WITHDRAWN

    Kansas City, Missouri, 64108, United States

  • Research Site

    RECRUITING

    Kansas City, Missouri, 64118, United States

  • Research Site

    NOT_YET_RECRUITING

    St Louis, Missouri, 63108, United States

  • Research Site

    RECRUITING

    Missoula, Montana, 59804, United States

  • Research Site

    RECRUITING

    Lincoln, Nebraska, 68510, United States

  • Research Site

    RECRUITING

    Lincoln, Nebraska, 68516, United States

  • Research Site

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Research Site

    RECRUITING

    Newark, New Jersey, 07103, United States

  • Research Site

    RECRUITING

    Northfield, New Jersey, 08225, United States

  • Research Site

    RECRUITING

    Ocean City, New Jersey, 07712, United States

  • Research Site

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • Research Site

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • Research Site

    RECRUITING

    Albany, New York, 12208, United States

  • Research Site

    RECRUITING

    Cortland, New York, 13045, United States

  • Research Site

    RECRUITING

    Hawthorne, New York, 10532, United States

  • Research Site

    WITHDRAWN

    Hollis, New York, 11423, United States

  • Research Site

    WITHDRAWN

    New York, New York, 10019, United States

  • Research Site

    RECRUITING

    New York, New York, 10032, United States

  • Research Site

    NOT_YET_RECRUITING

    New York, New York, 11355, United States

  • Research Site

    COMPLETED

    Rochester, New York, 14607, United States

  • Research Site

    RECRUITING

    The Bronx, New York, 10459, United States

  • Research Site

    RECRUITING

    The Bronx, New York, 10461, United States

  • Research Site

    RECRUITING

    Vestal, New York, 13850, United States

  • Research Site

    WITHDRAWN

    Vestal, New York, 13850, United States

  • Research Site

    RECRUITING

    Watertown, New York, 13601, United States

  • Research Site

    WITHDRAWN

    Charlotte, North Carolina, 28277, United States

  • Research Site

    NOT_YET_RECRUITING

    Durham, North Carolina, 27705, United States

  • Research Site

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Research Site

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • Research Site

    RECRUITING

    Columbus, Ohio, 43228, United States

  • Research Site

    RECRUITING

    Dayton, Ohio, 45424, United States

  • Research Site

    RECRUITING

    Findlay, Ohio, 45840, United States

  • Research Site

    RECRUITING

    Toledo, Ohio, 43617, United States

  • Research Site

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Research Site

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Research Site

    RECRUITING

    Yukon, Oklahoma, 73099, United States

  • Research Site

    RECRUITING

    Pittsburgh, Pennsylvania, 15241, United States

  • Research Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Research Site

    COMPLETED

    Rock Hill, South Carolina, 29730, United States

  • Research Site

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Research Site

    RECRUITING

    Austin, Texas, 78759, United States

  • Research Site

    RECRUITING

    Baytown, Texas, 77521, United States

  • Research Site

    RECRUITING

    Beaumont, Texas, 77701, United States

  • Research Site

    NOT_YET_RECRUITING

    Beaumont, Texas, 77702, United States

  • Research Site

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Research Site

    RECRUITING

    Corsicana, Texas, 75110, United States

  • Research Site

    RECRUITING

    Dallas, Texas, 75231, United States

  • Research Site

    NOT_YET_RECRUITING

    El Paso, Texas, 79912, United States

  • Research Site

    WITHDRAWN

    Frisco, Texas, 75034, United States

  • Research Site

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77065, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77099, United States

  • Research Site

    WITHDRAWN

    Kerrville, Texas, 78028, United States

  • Research Site

    RECRUITING

    McKinney, Texas, 75069, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78215, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Research Site

    NOT_YET_RECRUITING

    San Antonio, Texas, 78249, United States

  • Research Site

    COMPLETED

    Tyler, Texas, 75708, United States

  • Research Site

    RECRUITING

    West Jordan, Utah, 84088, United States

  • Research Site

    RECRUITING

    Burlington, Vermont, 05405, United States

  • Research Site

    WITHDRAWN

    Burke, Virginia, 22015, United States

  • Research Site

    COMPLETED

    Bellingham, Washington, 98225, United States

  • Research Site

    RECRUITING

    Vancouver, Washington, 98664, United States

  • Research Site

    RECRUITING

    Beijing, 100050, China

  • Research Site

    RECRUITING

    Beijing, 100191, China

  • Research Site

    RECRUITING

    Bengbu, 233004, China

  • Research Site

    RECRUITING

    Chengdu, 610066, China

  • Research Site

    RECRUITING

    Chongqing, 401122, China

  • Research Site

    RECRUITING

    Hohhot, 10050, China

  • Research Site

    RECRUITING

    Mianyang, 621000, China

  • Research Site

    RECRUITING

    Shanghai, 200062, China

  • Research Site

    RECRUITING

    Shanghai, 200433, China

  • Research Site

    RECRUITING

    Shanghai, China

  • Research Site

    RECRUITING

    Shantou, 515041, China

  • Research Site

    RECRUITING

    Shenyang, 110004, China

  • Research Site

    RECRUITING

    Shenzhen, 518026, China

  • Research Site

    RECRUITING

    Suzhou, 215002, China

  • Research Site

    RECRUITING

    Taizhou, 318000, China

  • Research Site

    RECRUITING

    Tianjin, 300050, China

  • Research Site

    RECRUITING

    Tianjin, 300134, China

  • Research Site

    RECRUITING

    Tianjin, 300211, China

  • Research Site

    RECRUITING

    Wuhan, 430000, China

  • Research Site

    RECRUITING

    Yanji, 133000, China

  • Research Site

    RECRUITING

    Yantai, 264000, China

  • Research Site

    RECRUITING

    Zhongshan, 528400, China

  • Research Site

    RECRUITING

    Chihuahua City, 31000, Mexico

  • Research Site

    RECRUITING

    Chihuahua City, 31238, Mexico

  • Research Site

    RECRUITING

    Guadalajara, 44100, Mexico

  • Research Site

    RECRUITING

    Guadalajara, 44500, Mexico

  • Research Site

    RECRUITING

    Monterrey, 64465, Mexico

  • Research Site

    RECRUITING

    Durban, 3630, South Africa

  • Research Site

    RECRUITING

    Durban, 4001, South Africa

  • Research Site

    RECRUITING

    Durban, 4092, South Africa

  • Research Site

    RECRUITING

    Krugersdorp, 1739, South Africa

  • Research Site

    RECRUITING

    Middelburg, 1055, South Africa

  • Research Site

    RECRUITING

    Panorama, 7500, South Africa

  • Research Site

    NOT_YET_RECRUITING

    Somerset West, 7130, South Africa

  • Research Site

    RECRUITING

    Welkom, 9460, South Africa

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