Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-01 @ 12:34 AM
Study NCT ID:
NCT07004595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Frailty in Patients With Fibrosing Interstitial Lung Diseases: Prognostic and Therapeutic Impact
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Evaluation of Frailty in Patients With Fibrosing Interstitial Lung Diseases: Prognostic and Therapeutic Impact
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
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:
FRAPID
Brief Summary:
Fibrosing interstitial lung diseases (ILDs), with idiopathic pulmonary fibrosis being the most common form, primarily affect older individuals and have a poor prognosis, with a median survival of 3 to 5 years. While antifibrotic treatments such as nintedanib and pirfenidone can slow disease progression, their efficacy is often limited by side effects, particularly in elderly patients. A comprehensive patient assessment, including evaluations of frailty and sarcopenia, could optimize care by identifying those at risk for poor outcomes or poor treatment tolerance. Frailty, characterized by reduced physiological reserves, and sarcopenia, defined as a loss of muscle mass and strength, are both associated with increased mortality and morbidity risks. Although their individual impacts on fibrosing ILDs have been documented, the combined effect of these two syndromes on patient prognosis remains unexplored, highlighting the need for further studies to guide therapeutic decision-making.
Detailed Description:
Frailty and sarcopenia are two distinct entities, each capable of worsening patient mortality and morbidity. Their association has been studied in the general population in a cohort of over 2,000 individuals aged 70 to 85 years (34816568). The prevalence of sarcopenia among frail participants was 40%. The characteristics and risks faced by patients who were both frail and sarcopenic differed from those who were only sarcopenic or only frail.
No study has evaluated the prognostic impact of the combined presence of sarcopenia and frailty on the outcomes of patients with fibrosing ILDs.
No study has evaluated the prognostic impact of the combined presence of sarcopenia and frailty on the outcomes of patients with fibrosing ILDs.
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?: