Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-13 @ 3:39 PM
Study NCT ID:
NCT01695408
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis
Sponsor:
Technische Universität Dresden
Organization:
Study Overview
Official Title:
Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.
Status:
COMPLETED
Status Verified Date:
2022-07
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:
INSIGHTS-IPF
Brief Summary:
Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the mean survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. As in Europe data are limited on the characteristics and management of such patients, INSIGHTS-IPF was initiated as a new registry that documents newly diagnosed (incident) and prevalent patients with confirmed IPF diagnosis prospectively.The registry will contribute to the optimization of the management of IPF patients in the long term.
Detailed Description:
INSIGHTS-IPF will report current and comprehensive data on Idiopathic Pulmonary Fibrosis (IPF) in the long-term.
Baseline (cross-sectional part): Description of characteristics of IPF patients in terms of
* key (socio-) demographic data
* IPF risk factors, comorbidities
* methods used for IPF diagnosis
* IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values, biomarkers)
* IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological treatment; listing and score for lung transplantation)
* assessment of patient-related outcomes (PRO) such as quality of life
Follow-up (prospectively up to at least 2 years after inclusion):
* Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if available)
* Documentation of treatment pathways (switch/add-on/discontinuation of medication), and of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing for lung transplantation)Outcomes/events (such as acute respiratory worsening, exacerbations, hospitalisation due to any cause and due to IPF, other complications, survival)
* Patient-related outcomes such as quality of life, assessed once a year(for comparison with baseline)
* Resource use for pharmacoeconomic analyses.
Baseline (cross-sectional part): Description of characteristics of IPF patients in terms of
* key (socio-) demographic data
* IPF risk factors, comorbidities
* methods used for IPF diagnosis
* IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values, biomarkers)
* IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological treatment; listing and score for lung transplantation)
* assessment of patient-related outcomes (PRO) such as quality of life
Follow-up (prospectively up to at least 2 years after inclusion):
* Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if available)
* Documentation of treatment pathways (switch/add-on/discontinuation of medication), and of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing for lung transplantation)Outcomes/events (such as acute respiratory worsening, exacerbations, hospitalisation due to any cause and due to IPF, other complications, survival)
* Patient-related outcomes such as quality of life, assessed once a year(for comparison with baseline)
* Resource use for pharmacoeconomic analyses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: