Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-12 @ 10:31 PM
Study NCT ID:
NCT03627858
Status:
COMPLETED
Last Update Posted:
2021-11-29
First Post:
2018-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting
Sponsor:
Chiesi SA/NV
Organization:
Study Overview
Official Title:
A Prospective Non-interventional Study in Patients With Chronic Obstructive Pulmonary Disease That Evolve to Fixed Long-acting Muscarinic Antagonist/Long-acting beta2-agonist/Inhaled Corticosteroid Triple Therapy, Trimbow®
Status:
COMPLETED
Status Verified Date:
2021-11
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:
TRIVOLVE
Brief Summary:
The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.
Detailed Description:
This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease.
This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.
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?: