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Two doses of inhaled glycopyrronium added to BFF for children 4 to less than 12 with asthma

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)

Phase 2 Interventional AstraZeneca · NCT07525375

This trial will test whether adding one of two doses of inhaled glycopyrronium to BFF improves lung function in children aged 4 to less than 12 who have asthma.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment69 (estimated)
Ages4 Years to 11 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsomalizumab, mepolizumab, benralizumab, reslizumab
Locations39 sites (Bakersfield, California and 38 other locations)
Trial IDNCT07525375 on ClinicalTrials.gov

What this trial studies

This Phase II, randomized, double-blind, 3-period, 6-sequence crossover study compares two doses of glycopyrronium MDI to placebo MDI when added to background BFF MDI in children 4 to under 12 with asthma. After a 3-week run-in on BFF, participants will be randomized to three 3-week treatment periods receiving BFF plus glycopyrronium dose A, BFF plus glycopyrronium dose B, or BFF plus placebo, with each participant cycling through all three treatments. Lung function (FEV1) is the primary measure during the treatment periods, and safety is monitored with a follow-up visit 12 to 16 days after the last dose. The study is multi-center and double-blinded to reduce bias and allow within-patient comparisons across doses.

Who should consider this trial

Good fit: Children aged 4 to less than 12 with physician-diagnosed asthma who are on a stable inhaled corticosteroid plus another controller, meet the study lung-function and weight/BMI requirements, and have the required screening scores are ideal candidates.

Not a fit: Children with a history of life-threatening asthma episodes, significant comorbid diseases, those outside the age/weight/BMI range, or those not on the specified background therapy are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could identify an effective glycopyrronium dose to improve lung function and symptom control as an add-on option for children already on inhaled corticosteroid-based therapy.

How similar studies have performed: Long-acting muscarinic antagonist add-on therapies have shown benefit in adults and older adolescents, but pediatric data are limited, so this approach is partly novel in younger children.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bakersfield, California and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaOral inhalationMetered dose inhalerAdd-on therapyInhaled corticosteroidLong-acting β2-agonistsLong-acting muscarinic antagonistLung Diseases
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.