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NCT07525375PHASE2Recruiting

A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma

AstraZeneca

Start Date

4/14/2026

Completion Date

5/23/2029

Summary

The purpose of this study is to evaluate the effect of 2 different GP metered dose inhaler (MDI) doses relative to placebo MDI as add-on treatment to BFF MDI on lung function in participants 4 to less than 12 years of age with asthma.

Detailed Description

This is a Phase II, multi-center, randomized, double-blind, 3-period, 6-sequence crossover study evaluating two doses of GP Metered-Dose Inhaler (MDI) compared with placebo MDI as add-on therapy to BFF MDI. The study comprises a 3-week run-in period, followed by three 3-week treatment periods where participants will be randomized to one of six treatment sequences, and a safety follow-up visit 12 to 16 days after the last dose of study intervention. The treatment periods are as follows: * Treatment A: BFF MDI + GP MDI Dose A * Treatment B: BFF MDI + GP MDI Dose B * Treatment C: BFF MDI + Placebo MDI

Eligibility Criteria

Age Range: 4 years to 11 years

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.

Interventions

COMBINATION_PRODUCT

GP MDI

COMBINATION_PRODUCT

BFF MDI

COMBINATION_PRODUCT

Placebo MDI

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Conditions

Asthma

Locations

Research Site

Bakersfield, California 93301

United States

Research Site

Long Beach, California 90806

United States

Research Site

San Diego, California 92123

United States

Research Site

Miami, Florida 33125

United States

Research Site

Pembroke Pines, Florida 33026

United States

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Owensboro, Kentucky 42301

United States

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Lafayette, Louisiana 70508

United States

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Boston, Massachusetts 02114

United States

Research Site

Columbia, Missouri 65203

United States

Research Site

Cincinnati, Ohio 45229

United States

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Oklahoma City, Oklahoma 73120

United States

Research Site

Buenos Aires, C1122

Argentina

Research Site

CABA, 1426

Argentina

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La Plata, B1900AXI

Argentina

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Lanús Este, B1824KAJ

Argentina

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Lobos, 7240

Argentina

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Mar del Plata, B7600

Argentina

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Mendoza, 5500

Argentina

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Mendoza, M5500

Argentina

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Rosario, 2000

Argentina

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Rosario, S2000CVD

Argentina

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San Juan Bautista, 1888

Argentina

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Santa Fe, 3000

Argentina

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Brno, 65691

Czechia

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Prague, 15006

Czechia

Research Site

Debrecen, 4032

Hungary

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Orosháza, 5900

Hungary

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Szeged, 6720

Hungary

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Székesfehérvár, 8000

Hungary

Research Site

Szigetvár, 7900

Hungary

Research Site

Apodaca, 64620

Mexico

Research Site

Guadalajara, 44130

Mexico

Research Site

San Juan, 00909

Mexico

Research Site

Lodz, 90-329

Poland

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Tarnów, 33-100

Poland

Research Site

Belgrade, 11000

Serbia

Research Site

Belgrade, 11040

Serbia

Research Site

Belgrade, 11070

Serbia

Research Site

Novi Sad, 21000

Serbia