A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease - THARROS

Study identifier:D5989C00001

ClinicalTrials.gov identifier:NCT06283966

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)

Medical condition

COPD (Chronic Obstructive Pulmonary Disease)

Phase

Phase 3

Healthy volunteers

No

Study drug

BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg

Sex

All

Estimated Enrollment

5000

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 21 Feb 2024
Estimated Primary Completion Date: 03 Mar 2028
Estimated Study Completion Date: 03 Mar 2028

Study design

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

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria