A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants with Inadequately Controlled Asthma (VATHOS) - VATHOS

Study identifier:D5982C00006

ClinicalTrials.gov identifier:NCT05202262

EudraCT identifier:2021-002026-24

CTIS identifier:2023-503334-45-00

Recruiting

Official Title

A Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort® Turbuhaler® in Participants with Inadequately Controlled Asthma (VATHOS).

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, BD MDI 320 μg, Open-label Symbicort TBH 320/9 μg

Sex

All

Estimated Enrollment

630

Study type

Interventional

Age

12 Years - 80 Years

Date

Study Start Date: 12 Jan 2022
Estimated Primary Completion Date: 02 Dec 2024
Estimated Study Completion Date: 02 Dec 2024

Study design

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

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria