Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480890
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-12
Brief Title:
Real-World Effectiveness of a Triple Combination BDPFFGB in a Single Pressurised Metered Dose Inhaler in COPD Patients TRIPHY
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
A 12-Week Single-Cohort Study to Evaluate Real-World Effectiveness of a Triple Combination Beclometasone DiproprionateFormoterol FumarateGlycopyrronium Bromide BDPFFGB in a Single Pressurised Metered Dose Inhaler Trimbow pMDI in Subjects With COPD
Status:
RECRUITING
Status Verified Date:
2024-06
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:
TRIPHY
Brief Summary:
The purpose of the study is to evaluate Real-World Effectiveness of a Triple Combination Beclometasone DiproprionateFormoterol FumarateGlycopyrronium Bromide BDPFFGB in a Single Pressurised Metered Dose Inhaler Trimbow pMDI in Subjects with Chronic Obstructive Pulmonary Disease COPD
Detailed Description:
This real-world study is a multi-centre single-cohort ambi-directional observational cohort study with both retrospective and prospective data collection with the primary objective to assess the 12-week effectiveness of BDPFFGB for COPD subjects in China The index date is the initiation date of BDPFFGB and subjects may have initiated treatment with BDPFFGB up to 12 weeks before enrolment Baseline period is the 12 weeks prior to index date The end of study EOS for each subject will be the earliest of the following approximately 12 weeks after BDPFFGB initiation the Week 12 Visit BDPFFGB discontinuation plus 2 weeks or at early withdrawal such as consent withdrawal death or lost to follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20241876 | REGISTRY | None | None |