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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

NCT07525375

RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: GP MDI, BFF MDI, Placebo MDI

Countries: United States, Argentina, Czechia, Hungary, Mexico, Poland, Serbia

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.

Eligibility overview

Sex: ALL

Age: 4 Years to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (39)

Bakersfield, California, United States
Long Beach, California, United States
San Diego, California, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Owensboro, Kentucky, United States
Lafayette, Louisiana, United States
Boston, Massachusetts, United States
Columbia, Missouri, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Buenos Aires, Argentina
CABA, Argentina
La Plata, Argentina
Lanús Este, Argentina
Lobos, Argentina
Mar del Plata, Argentina
Mendoza, Argentina
Mendoza, Argentina
Rosario, Argentina
Rosario, Argentina
San Juan Bautista, Argentina
Santa Fe, Argentina
Brno, Czechia
Prague, Czechia
Debrecen, Hungary
Orosháza, Hungary
Szeged, Hungary
Székesfehérvár, Hungary
Szigetvár, Hungary
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