THARROS
Research type
Research Study
Full 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)
IRAS ID
1009134
Contact name
Emma Greening
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a long-term condition caused by damage to and narrowing of the airways. This can lead to symptoms such as difficulty breathing, coughing, and phlegm. BGF (budesonide, glycopyrronium, and formoterol fumarate) or GFF (glycopyrronium and formoterol fumarate), the study treatments, are both recognised and licensed treatment options for COPD. People with COPD are at risk of COPD flare ups, and serious heart events including heart attacks and heart failure. This is because lung damage from COPD leads to deterioration in lung function leading to flare ups and air trapping in the lungs, and this can put more strain on the heart.
Because BGF has a steroid called budesonide in it that may help reduce inflammation, the researchers think that taking BGF may help prevent COPD flare ups and serious heart events in participants with COPD. So, the researchers want to learn how well BGF works compared to GFF and how safe BGF is.
The purpose of this study is to learn how well an inhaler called BGF works and how safe it is compared to an inhaler called GFF in adults with COPD who are at risk of COPD flare ups and serious heart events.
This study will include up to about 5,000 participants. All participants will be 40 to 80 years of age, have COPD, and be a current or former smoker. Participants must be at risk of developing COPD flare ups and serious heart events. Participants must not be taking any medication that has inhaled steroids in the previous 12 months.
Treatments and Procedures: All participants will take GFF twice a day for 2 weeks before being randomly assigned to one of the treatment groups Participants will take treatment for at least 3 months and up to 3 years.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0006
Date of REC Opinion
8 Feb 2024
REC opinion
Further Information Favourable Opinion