Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 12:25 AM
Study NCT ID:
NCT07073950
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORATOS
Brief Summary:
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
Detailed Description:
This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and pulmonary function will be evaluated in patients with COPD and hyperinflation.
The study will comprise of:
* Screening period
* Participants will receive placebo inhaler and salbutamol before randomization
* Two treatment periods where participants will be randomized 1:1 to receive either the study intervention BGF MDI followed by matching placebo or study interventions in reverse order
* A final follow-up period
The study will comprise of:
* Screening period
* Participants will receive placebo inhaler and salbutamol before randomization
* Two treatment periods where participants will be randomized 1:1 to receive either the study intervention BGF MDI followed by matching placebo or study interventions in reverse order
* A final follow-up period
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-521987-37-00 | OTHER | EU CT Number | View |