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 (41) 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
RECRUITING
Bakersfield
Research Site
RECRUITING
Lancaster
Research Site
RECRUITING
Long Beach
Research Site
NOT_YET_RECRUITING
San Diego
Florida
Research Site
RECRUITING
Miami
Research Site
RECRUITING
Pembroke Pines
Research Site
RECRUITING
Saint Cloud
Kentucky
Research Site
RECRUITING
Owensboro
Louisiana
Research Site
RECRUITING
Lafayette
Massachusetts
Research Site
NOT_YET_RECRUITING
Boston
Missouri
Research Site
RECRUITING
Columbia
Ohio
Research Site
NOT_YET_RECRUITING
Cincinnati
Oklahoma
Research Site
RECRUITING
Oklahoma City
Texas
Research Site
RECRUITING
Lewisville
Research Site
NOT_YET_RECRUITING
San Antonio
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
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.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca