What is Glycopyrronium studying for asthma in children?

Glycopyrronium is being studied to understand its effect on lung function when added to a background treatment of Budesonide and Formoterol Fumarate (BFF) in children aged 4 to less than 12 years with asthma. The research, sponsored by AstraZeneca, aims to evaluate two different doses compared to a placebo to see how they may impact breathing. Participants will receive these treatments in a controlled setting to monitor changes carefully.

Who may be eligible for this asthma clinical trial?

Children aged 4 to less than 12 years with a confirmed diagnosis of asthma may be eligible. They should have a stable use of inhaled corticosteroids plus another asthma controller and meet specific lung function and health criteria. Both boys and girls can join, but girls who have started menstruating must have a negative pregnancy test. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma clinical trial?

Study-related care, including the study medications and all trial visits, is provided at no cost. However, personal expenses such as travel or lodging may not be covered and can vary depending on your situation. Participants should plan accordingly for these possible costs.

Actively Recruiting

Phase 2

Age: 4Years - 11Years

All Genders

ID07525375

Phase II Study of Two Doses of Inhaled Glycopyrronium with Budesonide and Formoterol Fumarate in Children Aged 4 to Under 12 Years with Asthma

Led by AstraZeneca · Updated on 2026-04-22

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating two different doses of inhaled Glycopyrronium GP delivered by metered-dose inhaler MDI as add-on treatments to Budesonide and Formoterol Fumarate BFF MDI in children aged 4 to less than 12 years with asthma. This Phase II, multi-center, randomized, double-blind, crossover study aims to assess how these doses affect lung function compared to a placebo MDI added to BFF MDI. The study is designed to better understand the potential benefits and safety of these treatments in this young population with asthma. Participants will undergo a 3-week run-in period followed by three 3-week treatment periods. During the treatment periods, each participant will receive three treatments in different sequences BFF MDI combined with GP MDI Dose A, BFF MDI combined with GP MDI Dose B, and BFF MDI combined with placebo MDI. GP MDI and BFF MDI are both administered twice daily by oral inhalation. The study concludes with a safety follow-up visit 12 to 16 days after the last dose. Throughout the study, lung function will be closely monitored, with the primary outcome being the change from baseline in forced expiratory volume in one second FEV1 at 1-hour post-dose at the end of each 3-week treatment period. Additional measures include morning pre-dose trough FEV1 changes. Participants will attend scheduled visits for assessments, including lung function tests and safety evaluations, ensuring detailed monitoring of treatment effects and participant well-being during the study period.

CONDITIONS

Brief 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

Who Can Participate

Age: 4Years - 11Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants must have a documented history of physician-diagnosed asthma
Use stable and regular inhaled corticosteroid plus one additional asthma controller medication
Childhood Asthma Control Test score 19 or higher
Pre-bronchodilator FEV1 of 95% or less of predicted normal value
Body weight of 14 kg or higher and BMI at or below the 95th percentile for age
Female participants who have started menstruation must have a negative urine pregnancy test
No asthma medications other than run-in BFF MDI twice daily and albuterol/salbutamol as needed

You will not qualify if you...

History of life-threatening asthma episodes requiring intubation or associated with severe complications
Clinically significant diseases such as cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary conditions
Clinically relevant abnormal findings in physical exam, lab tests, vital signs, or ECG
Recent hospitalization for asthma
Untreated narrow-angle glaucoma or bladder dysfunction where anticholinergic treatment is contraindicated
Use of long-acting muscarinic antagonists (LAMA) or systemic beta-blockers
Respiratory infection requiring antibiotics
Use of systemic corticosteroids for any reason
Known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any MDI component
Inability to withhold short-acting bronchodilators and other asthma medications
Use of marketed or investigational biologic treatments for asthma
Regular use of nebulizers for asthma medication
Use of immunomodulators or immunosuppressive medications

Research Team

AstraZeneca Clinical Study Information Center

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