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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

Tracking Information
First Submitted Date September 26, 2012
First Posted Date September 28, 2012
Last Update Posted Date March 11, 2019
Actual Study Start Date October 2012
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2019)
Clinical course of IPF (in terms of symptoms, lung function, survival) [ Time Frame: up to 5 years after inclusion ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: March 8, 2019)
  • Characteristics of patients with IPF [ Time Frame: up to 5 years after inclusion ]
  • Treatment pathways [ Time Frame: up to 5 years after inclusion ]
  • 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis
Official Title Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current ATS/ERS guidelines)
Condition Idiopathic Pulmonary Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 8, 2019)
1100
Original Estimated Enrollment
 (submitted: September 27, 2012)
500
Estimated Study Completion Date September 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01695408
Other Study ID Numbers INSIGHTS-IPF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Technische Universität Dresden
Study Sponsor Technische Universität Dresden
Collaborators
  • GWT-TUD GmbH
  • Boehringer Ingelheim
Investigators
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
PRS Account Technische Universität Dresden
Verification Date March 2019