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OpenTrials
Completed

NCT Number: NCT01695408

Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Clinical Pharmacology, Medical Faculty, Technical University, Dresden, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical course of IPF (in terms of symptoms, lung function, survival)

    Time frame: up to 5 years after inclusion

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Boehringer Ingelheim
  • GWT-TUD GmbH

Registry information

Official study title

Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.

Acronym: INSIGHTS-IPF

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2012
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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