Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT06912659
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Non-interventional Prospective Study in Patients With Pulmonary Fibrosis Treated With Nintedanib Participating in a Patient Support Program in Spain, to Describe Patient Satisfaction With the Program and to Monitor Quality of Life - BALANCE Study
Status:
RECRUITING
Status Verified Date:
2025-06
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:
None
Brief Summary:
The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.
Detailed Description:
None
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?: