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)
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 11
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Research Site
NOT_YET_RECRUITING
Bakersfield
Research Site
NOT_YET_RECRUITING
Long Beach
Research Site
NOT_YET_RECRUITING
San Diego
Florida
Research Site
NOT_YET_RECRUITING
Miami
Research Site
NOT_YET_RECRUITING
Pembroke Pines
Kentucky
Research Site
RECRUITING
Owensboro
Louisiana
Research Site
NOT_YET_RECRUITING
Lafayette
Massachusetts
Research Site
NOT_YET_RECRUITING
Boston
Missouri
Research Site
NOT_YET_RECRUITING
Columbia
Ohio
Research Site
NOT_YET_RECRUITING
Cincinnati
Oklahoma
Research Site
NOT_YET_RECRUITING
Oklahoma City
Other Locations
Argentina
Research Site
NOT_YET_RECRUITING
Buenos Aires
Research Site
NOT_YET_RECRUITING
Caba
Research Site
NOT_YET_RECRUITING
La Plata
Research Site
NOT_YET_RECRUITING
Lanús Este
Research Site
NOT_YET_RECRUITING
Lobos
Research Site
NOT_YET_RECRUITING
Mar Del Plata
Research Site
NOT_YET_RECRUITING
Mendoza
Research Site
NOT_YET_RECRUITING
Mendoza
Research Site
NOT_YET_RECRUITING
Rosario
Research Site
NOT_YET_RECRUITING
Rosario
Research Site
NOT_YET_RECRUITING
San Juan Bautista
Research Site
NOT_YET_RECRUITING
Santa Fe
Hungary
Research Site
NOT_YET_RECRUITING
Debrecen
Research Site
NOT_YET_RECRUITING
Orosháza
Research Site
NOT_YET_RECRUITING
Szeged
Research Site
NOT_YET_RECRUITING
Székesfehérvár
Research Site
NOT_YET_RECRUITING
Szigetvár
Mexico
Research Site
NOT_YET_RECRUITING
Apodaca
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
San Juan
Poland
Research Site
NOT_YET_RECRUITING
Lodz
Research Site
NOT_YET_RECRUITING
Tarnów
Serbia
Research Site
NOT_YET_RECRUITING
Belgrade
Research Site
NOT_YET_RECRUITING
Belgrade
Research Site
NOT_YET_RECRUITING
Belgrade
Research Site
NOT_YET_RECRUITING
Novi Sad
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2026-04-14
Estimated Completion Date:2029-05-23
Participants
Target number of participants:69
Treatments
Experimental: Treatment Sequence ABC
Participants will receive three treatments in sequence: Treatment A, Treatment B followed by Treatment C for 3 weeks each.
Experimental: Treatment Sequence BCA
Participants will receive three treatments in sequence: Treatment B, Treatment C followed by Treatment A for 3 weeks each.
Experimental: Treatment Sequence CAB
Participants will receive three treatments in sequence: Treatment C, Treatment A followed by Treatment B for 3 weeks each.
Experimental: Treatment Sequence ACB
Participants will receive three treatments in sequence: Treatment A, Treatment C followed by Treatment B for 3 weeks each.
Experimental: Treatment Sequence BAC
Participants will receive three treatments in sequence: Treatment B, Treatment A followed by Treatment C for 3 weeks each.
Experimental: Treatment Sequence CBA
Participants will receive three treatments in sequence: Treatment C, Treatment B followed by Treatment A for 3 weeks each.