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New inhaler combo could help kids with asthma breathe easier

NCT ID NCT07525375

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This study tests whether adding an extra medication called glycopyrronium to standard asthma treatment can improve lung function in children aged 4 to 12. About 69 children with asthma will receive two different doses of glycopyrronium or a placebo, all on top of their usual inhaler. The goal is to see if the added drug helps open airways better than placebo.

What this could mean

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

Active substance
glycopyrronium (GP) metered dose inhaler
What this could lead to
If successful, this could provide an additional treatment option to help control asthma symptoms in young children.
What could go wrong
This is an early phase 2 study with only 69 participants, so results may not apply to all children. The added benefit over existing treatments is uncertain, and side effects 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 69 people

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

Started

Apr 2026

Expected to finish

May 2029

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

4 to 11 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.

Main Inclusion Criteria: * Participants who have a documented history of physician-diagnosed asthma * Participants who have been using a stable and regular inhaled corticosteroid plus one additional asthma controller medication. * Participants must have a Childhood Asthma Control Test score ≥ 19. * Participants must have a pre-bronchodilator FEV1 ≤ 95% of predicted normal value. * Body mass index (BMI) ≤ 95 percentile for age and body weight of ≥ 14 kg or higher. * Female participants who experience menarche must have a negative urine pregnancy test. * Received no asthma medication other than run-in BFF MDI BID and albuterol/salbutamol as needed. Main Exclusion Criteria: * Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). * Historical or current evidence of a clinically significant disease including, but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary. * Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG. * Hospitalization for asthma * Narrow-angle glaucoma not adequately treated and/or change in vision, bladder dysfunction, bladder outlet obstruction/urinary retention or any other conditions where anticholinergic treatment is contraindicated and may be relevant. * Use of Long-acting muscarinic antagonist (LAMA), either alone or as part of an inhaled combination therapy. * Current use of any systemic beta-blockers. * Respiratory infection involving antibiotic treatment. * Systemic corticosteroid use for any reason (including asthma exacerbations). * Participants with a known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any component of the MDI. * Participants who are medically unable to withhold their short-acting bronchodilators and other asthma medications. * Any use of marketed (eg, omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic. * Regular use of a nebulizer or a home nebulizer for receiving asthma medications. * Use of any immunomodulators or immunosuppressive medication.

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Conditions

The condition(s) this trial relates to.

asthma lung disorder

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

    43 sites in 7 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

    Bakersfield, California, 93301, United States

  • Research Site

    RECRUITING

    Lancaster, California, 93534, United States

  • Research Site

    RECRUITING

    Long Beach, California, 90806, United States

  • Research Site

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33186, United States

  • Research Site

    RECRUITING

    Pembroke Pines, Florida, 33026, United States

  • Research Site

    RECRUITING

    Saint Cloud, Florida, 34769, United States

  • Research Site

    RECRUITING

    Owensboro, Kentucky, 42301, United States

  • Research Site

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Research Site

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    Columbia, Missouri, 65203, United States

  • Research Site

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Research Site

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Research Site

    RECRUITING

    Lewisville, Texas, 75067, United States

  • Research Site

    NOT_YET_RECRUITING

    San Antonio, Texas, 78249, United States

  • Research Site

    NOT_YET_RECRUITING

    Buenos Aires, C1122, Argentina

  • Research Site

    NOT_YET_RECRUITING

    CABA, 1426, Argentina

  • Research Site

    NOT_YET_RECRUITING

    La Plata, B1900AXI, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Lanús Este, B1824KAJ, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Lobos, 7240, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mar del Plata, B7600, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mendoza, 5500, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mendoza, M5500, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Rosario, 2000, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Rosario, S2000CVD, Argentina

  • Research Site

    NOT_YET_RECRUITING

    San Juan Bautista, 1888, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Santa Fe, 3000, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Brno, 65691, Czechia

  • Research Site

    NOT_YET_RECRUITING

    Prague, 15006, Czechia

  • Research Site

    NOT_YET_RECRUITING

    Debrecen, 4032, Hungary

  • Research Site

    NOT_YET_RECRUITING

    Orosháza, 5900, Hungary

  • Research Site

    RECRUITING

    Szeged, 6720, Hungary

  • Research Site

    NOT_YET_RECRUITING

    Székesfehérvár, 8000, Hungary

  • Research Site

    NOT_YET_RECRUITING

    Szigetvár, 7900, Hungary

  • Research Site

    NOT_YET_RECRUITING

    Apodaca, 64620, Mexico

  • Research Site

    NOT_YET_RECRUITING

    Guadalajara, 44130, Mexico

  • Research Site

    NOT_YET_RECRUITING

    San Juan, 00909, Mexico

  • Research Site

    NOT_YET_RECRUITING

    Lodz, 90-329, Poland

  • Research Site

    NOT_YET_RECRUITING

    Tarnów, 33-100, Poland

  • Research Site

    NOT_YET_RECRUITING

    Belgrade, 11000, Serbia

  • Research Site

    NOT_YET_RECRUITING

    Belgrade, 11040, Serbia

  • Research Site

    NOT_YET_RECRUITING

    Belgrade, 11070, Serbia

  • Research Site

    NOT_YET_RECRUITING

    Novi Sad, 21000, Serbia

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