Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis (INSIGHTS-IPF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Technische Universität Dresden
Sponsor:
Collaborators:
GWT-TUD GmbH
Boehringer Ingelheim
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01695408
First received: September 26, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition
Idiopathic Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Estimated Enrollment: 500
Study Start Date: October 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current ATS/ERS guidelines)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695408

Contacts
Contact: Juergen Behr, MD 089 85791 ext 4101 j.behr@asklepios.com
Contact: David Pittrow, MD 49 351 458 ext 2815 david.pittrow@mailbox.tu-dresden.de

Locations
Germany
Klinik III für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin, Berufs¬genossen-schaftliches Universitätsklinikum Bergmannsheil GmbH Recruiting
Bochum, Germany
Contact: Jurgen Behr, MD         
Principal Investigator: Juergen Behr, MD         
Institute for Clinical Pharmacology, Medical Faculty, Technical University Active, not recruiting
Dresden, Germany, 01307
Klinik für Pneumologie, Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Contact: Marius Hoeper, MD    +49511 532 ext 3934    pneumologie@mh-hannover.de   
Principal Investigator: Marius M Hoeper, MD         
Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum Recruiting
Heidelberg, Germany, 69126
Contact: Michael Kreuter, MD    +496221396 ext 1214    michael.kreuter@thoraxklinik-heidelberg.de   
Principal Investigator: Michael Kreuter, MD         
Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR Recruiting
Leipzig, Germany
Contact: Hubert Wirtz, MD       hubert.wirtz@medizin.uni-leipzig.de   
Principal Investigator: Hubert Wirtz, MD         
Sponsors and Collaborators
Technische Universität Dresden
GWT-TUD GmbH
Boehringer Ingelheim
Investigators
Study Chair: Wilhelm Kirch, MD, PhD Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
Principal Investigator: Juergen Behr, MD Asklepios Fachkliniken München Gauting Medizinischen Klinik und Poliklinik V Klinikum der Ludwig-Maximilians-Universität München Comprehensive Pneumology Center Munich (CPC-M) Mitglied des Deutschen Zentrums für Lungenforschung (DZL)
Study Director: David Pittrow, MD Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden
  More Information

Additional Information:
Publications:
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01695408     History of Changes
Other Study ID Numbers: INSIGHTS-IPF
Study First Received: September 26, 2012
Last Updated: July 16, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
Drug Treatment
Treatment pathways
Clinical routine
Registry
Outcomes
Survival
Patient-related outcomes
Quality of life
Steroids
Azathioprine
N-Acetylcysteine
Pirfenidone
Tyrosine kinase inhibitors
Nintedanib
multicenter
Germany
Safety
Adverse event

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on September 14, 2014