ORATOS
Research type
Research Study
Full title
A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants with Chronic Obstructive Pulmonary Disease and Hyperinflation (ORATOS)
IRAS ID
1012100
Contact name
Eva Shrestha
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
COPD (Chronic Obstructive Pulmonary Disease) is a serious lung condition that causes breathing difficulties and can significantly impact quality of life. COPD includes conditions such as chronic bronchitis and emphysema, and is primarily caused by smoking but can also be triggered by other factors like air pollution and workplace exposures. Early diagnosis and management are crucial to slow disease progression and manage symptoms.
The primary purpose of this study is to evaluate the effect of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler (BGF MDI) compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
It is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study that will recruit people aged between 40 and 80 years old who are a current or former smoker.
The study will comprise of:
- Screening period (Day -21 to Day -14)
- Participants will receive placebo inhaler and salbutamol for 14 days before randomization
- Two treatment periods where participants will be randomized to 1:1 to receive either the study intervention BGF MDI followed by
matching placebo or study interventions in reverse order for 21 days - A final follow-up period (Day 57 or 14 days post last dose)REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0151
Date of REC Opinion
9 Oct 2025
REC opinion
Further Information Favourable Opinion