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

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ClinicalTrials.gov Identifier: NCT01695408
Recruitment Status : Recruiting
First Posted : September 28, 2012
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
GWT-TUD GmbH
Boehringer Ingelheim
Information provided by (Responsible Party):
Technische Universität Dresden

Study Description
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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.

Condition or disease
Idiopathic Pulmonary Fibrosis

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 Design
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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.
Actual Study Start Date : October 2012
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Clinical course of IPF (in terms of symptoms, lung function, survival) [ Time Frame: up to 5 years after inclusion ]

Secondary Outcome Measures :
  1. Characteristics of patients with IPF [ Time Frame: up to 5 years after inclusion ]
  2. Treatment pathways [ Time Frame: up to 5 years after inclusion ]
  3. Functionality and quality of life [ Time Frame: up to 5 years after inclusion ]
    St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695408


Contacts
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Contact: Juergen Behr, MD 089 85791 ext 4101 j.behr@asklepios.com
Contact: David Pittrow, MD, PhD +49 351 25933 ext 182 david.pittrow@mailbox.tu-dresden.de

Locations
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Germany
Institute for Clinical Pharmacology, Medical Faculty, Technical University Active, not recruiting
Dresden, Germany, 01307
Klinik für Pneumologie, Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Contact: Antje Prasse, MD    +49511 532 ext 3934    pneumologie@mh-hannover.de   
Principal Investigator: Antje Prasse, 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         
V. Med. Clinic, Ludwig-Maximilians-Unviversity Recruiting
München, Germany
Contact: Jürgen Behr, MD         
Sponsors and Collaborators
Technische Universität Dresden
GWT-TUD GmbH
Boehringer Ingelheim
Investigators
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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 Chair: David Pittrow, MD Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01695408    
Other Study ID Numbers: INSIGHTS-IPF
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial