Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01695408
Study type	Observational
Source	Technische Universität Dresden
Contact
Status	Completed
Phase
Start date	October 2012
Completion date	December 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05984992` - The First-in-human Study of SRN-001 in Healthy Participants	Phase 1
Active, not recruiting	`NCT04312594` - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT03865927` - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis	Phase 2
Completed	`NCT03979430` - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study	N/A
Enrolling by invitation	`NCT04905693` - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis	Phase 3
Terminated	`NCT04419558` - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 3
Completed	`NCT03725852` - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 2
Terminated	`NCT03573505` - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT04148157` - Quality of Life in IPF - Patient and Physician Perceptions
Active, not recruiting	`NCT03222648` - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis	N/A
Completed	`NCT02257177` - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients	Phase 1/Phase 2
Completed	`NCT02268981` - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)	N/A
Withdrawn	`NCT01524068` - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations	Phase 2
Enrolling by invitation	`NCT01382368` - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients	Phase 4
Completed	`NCT01199887` - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis	Phase 1
Completed	`NCT01110694` - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Active, not recruiting	`NCT02951416` - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated	`NCT00981747` - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis	Phase 2/Phase 3
Completed	`NCT00532233` - SD, IL-13 Production Rate in IPF	Phase 2
Completed	`NCT00540475` - Pennsylvania Idiopathic Pulmonary Fibrosis Research Registry

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis — INSIGHTS-IPF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms