A study to investigate efficacy and safety of PT027 compared with PT007 in symptomatic Chinese adults with asthma - BAIYUN

Study identifier:D6935C00003

ClinicalTrials.gov identifier:NCT06471257

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Randomized, Double-blind, Multicentre, Event-driven, Parallel group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Symptomatic Chinese Adults with Asthma (BAIYUN)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

Budesonide/Albuterol metered dose inhaler, MDI, Albuterol sulfate metered dose inhaler, MDI

Sex

All

Estimated Enrollment

790

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 17 Jun 2024
Estimated Primary Completion Date: 16 Sept 2026
Estimated Study Completion Date: 16 Sept 2026

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria