Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-02 @ 2:17 AM
Study NCT ID:
NCT03842904
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing the Effects of Trimbow to Fostair in COPD
Sponsor:
Medicines Evaluation Unit Ltd
Organization:
Study Overview
Official Title:
A Randomised, Open Label 2-Way Cross-over Study to Compare the Effects of Inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on Hyperinflation and Expiratory Flow Limitation in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIFLOW
Brief Summary:
A randomised, open label 2-way cross-over study to compare the effects of inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic obstructive pulmonary disease (COPD).
Detailed Description:
This study will investigate the contributions of extra-fine glycopyrronium and formoterol (within triple therapy) to improvements in small airway function in COPD patients. This will be achieved by recruiting patients with hyperinflation, and measuring improvements in hyperinflation and expiratory flow limitation as measurements of small airway disease.
This study will help understand the mechanisms of action of the bronchodilators within BDP/FF/GB, and potentially encourage treatment of small airway disease in COPD with extra-fine bronchodilator treatments. This trial will be conducted in compliance with the Declaration of Helsinki (1964 and amendments) current Good Clinical Practices and all other applicable laws and regulations.
This study will help understand the mechanisms of action of the bronchodilators within BDP/FF/GB, and potentially encourage treatment of small airway disease in COPD with extra-fine bronchodilator treatments. This trial will be conducted in compliance with the Declaration of Helsinki (1964 and amendments) current Good Clinical Practices and all other applicable laws and regulations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| 2018-003113-17 | EUDRACT_NUMBER | None | View |