Tests inhaled glycopyrronium added to budesonide and formoterol in children with asthma
Tests inhaled glycopyrronium with budesonide and formoterol in children aged 4 to 11 with asthma.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Apodaca, Guadalajara, and San Juan, MexicoSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 11 years old?
Source: NCT07525375, who can take part
Where in Mexico
- ApodacaApodaca, MexicoNot yet recruiting
- GuadalajaraGuadalajara, MexicoNot yet recruiting
- San JuanSan Juan, MexicoNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07525375EU 2025-524914-26-00
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
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.