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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01695408
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : July 27, 2022
Sponsor:
Collaborators:
GWT-TUD GmbH
Boehringer Ingelheim
Information provided by (Responsible Party):
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.

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.

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Study Type : Observational
Actual Enrollment : 1232 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
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021





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



Information from the National Library of Medicine

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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

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


Locations
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Germany
Institute for Clinical Pharmacology, Medical Faculty, Technical University
Dresden, Germany, 01307
Klinik für Pneumologie, Medizinische Hochschule Hannover
Hannover, Germany
Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum
Heidelberg, Germany, 69126
Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR
Leipzig, Germany
V. Med. Clinic, Ludwig-Maximilians-Unviversity
München, Germany
Sponsors and Collaborators
Technische Universität Dresden
GWT-TUD GmbH
Boehringer Ingelheim
Investigators
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Principal Investigator: Juergen Behr, MD, PhD Ludwig-Maximilian University (LMU) Munich, Med. Clinic V
Study Chair: David Pittrow, MD, PhD Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden
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: July 27, 2022
Last Verified: July 2022
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