Study identifier:D6934C00001
ClinicalTrials.gov identifier:NCT06307665
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-blind, Multicenter, Parallel group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Participants 12 to < 18 Years of Age with Asthma (ACADIA)
asthma
Phase 3
No
BDA MDI, AS MDI
All
440
Interventional
12 Years - 17 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Budesonide/albuterol metered -dose inhaler (BDA MDI) Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed. | Combination Product: BDA MDI Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed. Other Name: PT027 |
Active Comparator: Albuterol sulfate metered-dose inhaler (AS MDI) Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed. | Combination Product: AS MDI Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed. Other Name: PT007 |