Ireland
--:--IST
Recruiting Phase 2

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 · tracked via the Priya Life Science Poland tracker
Phase
Phase 2
Started
2026-04-14
Last updated
2026-10-13

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

GP MDIBFF MDIPlacebo MDI

GP MDI: GP MDI will be administered via oral inhalation twice daily (BID).

BFF MDI: BFF MDI will be administered via oral inhalation BID.

Placebo MDI: Placebo MDI will be adminsitered via oral inhalation BID.

Study 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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from baseline in Forced Expiratory volume in one second (FEV1) at 1-hour post-dose measured at End of treatment (EoT) — at 3 weeks
    Evaluate the effect of 2 different GP MDI doses relative to placebo MDI as an add-on treatment to BFF MDI on lung function in 4 to less than 12 years old participants with asthma.

Trial sites (44)

FacilityCityRegionStatus
Research Site Bakersfield California Recruiting
Research Site Lancaster California Recruiting
Research Site Long Beach California Recruiting
Research Site San Diego California Not Yet Recruiting
Research Site Miami Florida Recruiting
Research Site Pembroke Pines Florida Recruiting
Research Site Saint Cloud Florida Recruiting
Research Site Owensboro Kentucky Recruiting
Research Site Lafayette Louisiana Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Columbia Missouri Recruiting
Research Site Cincinnati Ohio Not Yet Recruiting
Research Site Oklahoma City Oklahoma Recruiting
Research Site Lewisville Texas Recruiting
Research Site San Antonio Texas Recruiting
Research Site Buenos Aires Argentina Recruiting
Research Site CABA Argentina Recruiting
Research Site La Plata Argentina Not Yet Recruiting
Research Site Lanús Este Argentina Not Yet Recruiting
Research Site Lobos Argentina Not Yet Recruiting
Research Site Mar del Plata Argentina Not Yet Recruiting
Research Site Mendoza Argentina Not Yet Recruiting
Research Site Mendoza Argentina Recruiting
Research Site Rosario Argentina Not Yet Recruiting
Research Site Rosario Argentina Recruiting
Research Site San Juan Bautista Argentina Not Yet Recruiting
Research Site Santa Fe Argentina Not Yet Recruiting
Research Site Brno Czechia Not Yet Recruiting
Research Site Prague Czechia Not Yet Recruiting
Research Site Budapest Hungary Not Yet Recruiting
Research Site Debrecen Hungary Recruiting
Research Site Orosháza Hungary Not Yet Recruiting
Research Site Szeged Hungary Recruiting
Research Site Székesfehérvár Hungary Not Yet Recruiting
Research Site Szigetvár Hungary Recruiting
Research Site Apodaca Mexico Not Yet Recruiting
Research Site Guadalajara Mexico Not Yet Recruiting
Research Site San Juan Mexico Not Yet Recruiting
Research Site Lodz Poland Recruiting
Research Site Tarnów Poland Not Yet Recruiting

+ 4 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07525375 on ClinicalTrials.gov ↗ ← All trials in Poland