Recruiting
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
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.
ClinicalTrials.gov IDNCT07525375
PhasePHASE2
Enrollment69
SponsorAstraZeneca
Age4 Years
SexALL
Conditions studied
Asthma
About this study
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.
Interventions
- Combination Product: GP MDI — GP MDI will be administered via oral inhalation twice daily (BID).
- Combination Product: BFF MDI — BFF MDI will be administered via oral inhalation BID.
- Combination Product: Placebo MDI — Placebo MDI will be adminsitered via oral inhalation BID.
Primary outcomes
- 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)
Eligibility information
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.
Study locations
- Research Site, Bakersfield, California 93301 United States
- Research Site, Lancaster, California 93534 United States
- Research Site, Long Beach, California 90806 United States
- Research Site, San Diego, California 92123 United States
- Research Site, Miami, Florida 33186 United States
- Research Site, Pembroke Pines, Florida 33026 United States
- Research Site, Saint Cloud, Florida 34769 United States
- Research Site, Owensboro, Kentucky 42301 United States
- Research Site, Lafayette, Louisiana 70508 United States
- Research Site, Boston, Massachusetts 02114 United States
Showing 10 of 43 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.