Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— INSIGHTS-IPF  

Official title:

Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695408
• Other study ID #: INSIGHTS-IPF
• Status: Completed
• Start date: October 2012
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1232
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
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	V. Med. Clinic, Ludwig-Maximilians-Unviversity	München

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	Boehringer Ingelheim, GWT-TUD GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. [Characteristics and management of idiopathic pulmonary fibrosis: INSIGHTS-IPF registry]. Dtsch Med Wochenschr. 2012 Dec;137(49):2586-8. doi: 10.1055/s-0032-1327244. Epub 2012 Nov 27. Review. German. — View Citation

Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. Investigating significant health trends in idiopathic pulmonary fibrosis (INSIGHTS-IPF): rationale, aims and design of a nationwide prospective registry. BMJ Open Respir Res. 2014 Jan 3;1(1):e000010. doi: 10.1136/bmjresp-2013-000010. eCollection 2014. Erratum in: BMJ Open Respir Res. 2014;1(1):e000010corr1. — View Citation

Behr J, Kreuter M, Hoeper MM, Wirtz H, Klotsche J, Koschel D, Andreas S, Claussen M, Grohé C, Wilkens H, Randerath W, Skowasch D, Meyer FJ, Kirschner J, Gläser S, Herth FJ, Welte T, Huber RM, Neurohr C, Schwaiblmair M, Kohlhäufl M, Höffken G, Held M, Koch — View Citation

Behr J, Prasse A, Wirtz H, Koschel D, Pittrow D, Held M, Klotsche J, Andreas S, Claussen M, Grohé C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Gläser S, Kahn N, Welte T, Neurohr C, Schwaiblmair M, Bahmer T, Oqueka T, Frankenberger M, Kreut — View Citation

Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohé C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Gläser S, Herth FJF, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Franke — View Citation

Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohé C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Gläser S, Kahn N, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Oqueka T, — View Citation

Leuschner G, Klotsche J, Kreuter M, Prasse A, Wirtz H, Pittrow D, Frankenberger M, Behr J, Kneidinger N; INSIGHTS-IPF Registry Group. Idiopathic Pulmonary Fibrosis in Elderly Patients: Analysis of the INSIGHTS-IPF Observational Study. Front Med (Lausanne) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical course of IPF (in terms of symptoms, lung function, survival)		up to 5 years after inclusion
Secondary	Characteristics of patients with IPF		up to 5 years after inclusion
Secondary	Treatment pathways		up to 5 years after inclusion
Secondary	Functionality and quality of life	St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions	up to 5 years after inclusion

External Links

•   Study website