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

Официальное название

A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) Versus Placebo in Participants of 4 to Less Than 12 Years of Age With Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF)

Обзор

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.

Подробное описание

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

Вмешательства

• Комбинированный продукт GP MDI
  GP MDI will be administered via oral inhalation twice daily (BID).
• Комбинированный продукт BFF MDI
  BFF MDI will be administered via oral inhalation BID.
• Комбинированный продукт Placebo MDI
  Placebo MDI will be adminsitered via oral inhalation BID.

Первичные конечные точки

• Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT) [Срок оценки: at 3 weeks]

Вторичные конечные точки (1)

• Change from baseline in morning pre-dose trough FEV1 at EOT [Срок оценки: at 3 weeks]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Аргентина · 12 центров

• Research Site — Buenos Aires
• Research Site — CABA
• Research Site — La Plata
• Research Site — Lanús Este
• Research Site — Lobos
• Research Site — Mar del Plata
• Research Site — Mendoza
• Research Site — Mendoza
• … и ещё 4 центра

США · 11 центров

• Research Site — Bakersfield
• Research Site — Long Beach
• Research Site — San Diego
• Research Site — Miami
• Research Site — Pembroke Pines
• Research Site — Owensboro
• Research Site — Lafayette
• Research Site — Boston
• … и ещё 3 центра

Венгрия · 5 центров

• Research Site — Debrecen
• Research Site — Orosháza
• Research Site — Szeged
• Research Site — Székesfehérvár
• Research Site — Szigetvár

Сербия · 4 центра

• Research Site — Belgrade
• Research Site — Belgrade
• Research Site — Belgrade
• Research Site — Novi Sad

Мексика · 3 центра

• Research Site — Apodaca
• Research Site — Guadalajara
• Research Site — San Juan

Чехия · 2 центра

• Research Site — Brno
• Research Site — Prague

Польша · 2 центра

• Research Site — Lodz
• Research Site — Tarnów

Идентификаторы

NCT: NCT07525375 · D5982C00015 · 2025-524914-26-00 · EMEA-002063-PIP01-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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