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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 : September 14, 2018
Sponsor:
Collaborators:
GWT-TUD GmbH
Boehringer Ingelheim
Information provided by (Responsible Party):
Technische Universität Dresden

September 26, 2012
September 28, 2012
September 14, 2018
October 2012
December 2019   (Final data collection date for primary outcome measure)
Clinical course of IPF (in terms of symptoms, lung function, survival) [ Time Frame: up to 4 years after inclusion ]
Not Provided
Complete list of historical versions of study NCT01695408 on ClinicalTrials.gov Archive Site
  • Characteristics of patients with IPF [ Time Frame: up to 4 years after inclusion ]
  • Treatment pathways [ Time Frame: up to 4 years after inclusion ]
  • Functionality and quality of life [ Time Frame: up to 4 years after inclusion ]
    St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions
Not Provided
Not Provided
Not Provided
 
Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis
Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current ATS/ERS guidelines)
Idiopathic Pulmonary Fibrosis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
500
April 2020
December 2019   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
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
Germany
 
 
NCT01695408
INSIGHTS-IPF
No
Not Provided
Plan to Share IPD: No
Technische Universität Dresden
Technische Universität Dresden
  • GWT-TUD GmbH
  • Boehringer Ingelheim
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
Technische Universität Dresden
September 2018