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New asthma drug cuts severe attacks in Hard-to-Treat patients

NCT ID NCT05329194

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tested a drug called tezepelumab in 287 adults and teens with severe asthma, including groups often left out of research. The goal was to see if the drug reduces asthma attacks and is safe over 52 weeks. Results showed fewer flare-ups compared to the year before starting the drug.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

286 people

The number who actually took part.

Started

Apr 2022

Finished

Oct 2025

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 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: * Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent. * Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses. * Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months prior to enrollment. * Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months prior to enrollment. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting β-agonist (LABA)). * Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment. * Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI). * Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists). * Provision of signed and dated written informed consent form. Exclusion Criteria: * Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator. * Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021). * Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer) prior to enrollment. * Participation in an interventional clinical trial for asthma within 12 months prior to enrollment. * Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

  • Research Site

    Mobile, Alabama, 36608, United States

  • Research Site

    Gilbert, Arizona, 85234, United States

  • Research Site

    Long Beach, California, 90815, United States

  • Research Site

    Los Angeles, California, 90017, United States

  • Research Site

    Rancho Mirage, California, 92270, United States

  • Research Site

    Westminster, California, 92683, United States

  • Research Site

    Colorado Springs, Colorado, 80907, United States

  • Research Site

    New Haven, Connecticut, 06510, United States

  • Research Site

    Washington D.C., District of Columbia, 20037, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Lexington, Kentucky, 40509, United States

  • Research Site

    New Orleans, Louisiana, 70112, United States

  • Research Site

    Upper Marlboro, Maryland, 20772, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Ypsilanti, Michigan, 48197, United States

  • Research Site

    Saint Paul, Minnesota, 55109, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Lincoln, Nebraska, 68505, United States

  • Research Site

    Omaha, Nebraska, 68114, United States

  • Research Site

    Hollis, New York, 11423, United States

  • Research Site

    Horseheads, New York, 14845, United States

  • Research Site

    Rochester, New York, 14642, United States

  • Research Site

    Valhalla, New York, 10595, United States

  • Research Site

    Chapel Hill, North Carolina, 27514, United States

  • Research Site

    Wilmington, North Carolina, 28401, United States

  • Research Site

    Toledo, Ohio, 43617, United States

  • Research Site

    Oklahoma City, Oklahoma, 73120, United States

  • Research Site

    Altoona, Pennsylvania, 16602, United States

  • Research Site

    Philadelphia, Pennsylvania, 19140, United States

  • Research Site

    Warwick, Rhode Island, 02886, United States

  • Research Site

    Greenville, South Carolina, 29607, United States

  • Research Site

    Hendersonville, Tennessee, 37075, United States

  • Research Site

    Fort Worth, Texas, 76104, United States

  • Research Site

    McKinney, Texas, 75069, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Charlottesville, Virginia, 22903, United States

  • Research Site

    Vancouver, Washington, 98664, United States

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