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
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 (43)
Facility
City
Region
Status
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
Not Yet Recruiting
Research Site
Buenos Aires
Argentina
Not Yet Recruiting
Research Site
CABA
Argentina
Not Yet 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
Not Yet Recruiting
Research Site
Rosario
Argentina
Not Yet Recruiting
Research Site
Rosario
Argentina
Not Yet 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
Debrecen
Hungary
Not Yet Recruiting
Research Site
Orosháza
Hungary
Not Yet Recruiting
Research Site
Szeged
Hungary
Recruiting
Research Site
Székesfehérvár
Hungary
Not Yet Recruiting
Research Site
Szigetvár
Hungary
Not Yet 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
Not Yet Recruiting
Research Site
Tarnów
Poland
Not Yet Recruiting
Research Site
Belgrade
Serbia
Not Yet Recruiting
+ 3 more sites — see the full list on the official registry below.
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.
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