Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Participants 12 to < 18 Years of Age with Asthma - ACADIA

Study identifier:D6934C00001

ClinicalTrials.gov identifier:NCT06307665

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

BDA MDI, AS MDI

Sex

All

Estimated Enrollment

440

Study type

Interventional

Age

12 Years - 17 Years

Date

Study Start Date: 20 May 2024
Estimated Primary Completion Date: 13 Oct 2027
Estimated Study Completion Date: 13 Oct 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria