Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis

Completed

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT01695408
• Lead Sponsor: Technische Universität Dresden

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.

Study Timeline

• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Study Start: 2012-10
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1232

Inclusion Criteria

• At least 18 years of age
• Written informed consent for participation in the registry
• Newly diagnosed (incident) or known (prevalent) IPF (based on diagnosis of treating physician)

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical course of IPF (in terms of symptoms, lung function, survival)	up to 5 years after inclusion

Secondary Outcome Measures

Name	Time	Method
Treatment pathways	up to 5 years after inclusion
Characteristics of patients with IPF	up to 5 years after inclusion
Functionality and quality of life	up to 5 years after inclusion	St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions

Trial Locations

Locations (5)

V. Med. Clinic, Ludwig-Maximilians-Unviversity; 🇩🇪 München, Germany

Institute for Clinical Pharmacology, Medical Faculty, Technical University; 🇩🇪 Dresden, Germany

Klinik für Pneumologie, Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum; 🇩🇪 Heidelberg, Germany

Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR; 🇩🇪 Leipzig, Germany