<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01695408</url>
  </required_header>
  <id_info>
    <org_study_id>INSIGHTS-IPF</org_study_id>
    <nct_id>NCT01695408</nct_id>
  </id_info>
  <brief_title>Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis</brief_title>
  <acronym>INSIGHTS-IPF</acronym>
  <official_title>Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GWT-TUD GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing&#xD;
      interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the mean&#xD;
      survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. As in&#xD;
      Europe data are limited on the characteristics and management of such patients, INSIGHTS-IPF&#xD;
      was initiated as a new registry that documents newly diagnosed (incident) and prevalent&#xD;
      patients with confirmed IPF diagnosis prospectively.The registry will contribute to the&#xD;
      optimization of the management of IPF patients in the long term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INSIGHTS-IPF will report current and comprehensive data on Idiopathic Pulmonary Fibrosis&#xD;
      (IPF) in the long-term.&#xD;
&#xD;
      Baseline (cross-sectional part): Description of characteristics of IPF patients in terms of&#xD;
&#xD;
        -  key (socio-) demographic data&#xD;
&#xD;
        -  IPF risk factors, comorbidities&#xD;
&#xD;
        -  methods used for IPF diagnosis&#xD;
&#xD;
        -  IPF disease severity and manifestation (including lung function, cardiopulmonary&#xD;
           exercise testing and/or exercise capacity if available, laboratory values, biomarkers)&#xD;
&#xD;
        -  IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological&#xD;
           treatment; listing and score for lung transplantation)&#xD;
&#xD;
        -  assessment of patient-related outcomes (PRO) such as quality of life&#xD;
&#xD;
      Follow-up (prospectively up to at least 2 years after inclusion):&#xD;
&#xD;
        -  Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if&#xD;
           available)&#xD;
&#xD;
        -  Documentation of treatment pathways (switch/add-on/discontinuation of medication), and&#xD;
           of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing&#xD;
           for lung transplantation)Outcomes/events (such as acute respiratory worsening,&#xD;
           exacerbations, hospitalisation due to any cause and due to IPF, other complications,&#xD;
           survival)&#xD;
&#xD;
        -  Patient-related outcomes such as quality of life, assessed once a year(for comparison&#xD;
           with baseline)&#xD;
&#xD;
        -  Resource use for pharmacoeconomic analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical course of IPF (in terms of symptoms, lung function, survival)</measure>
    <time_frame>up to 5 years after inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of patients with IPF</measure>
    <time_frame>up to 5 years after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment pathways</measure>
    <time_frame>up to 5 years after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality and quality of life</measure>
    <time_frame>up to 5 years after inclusion</time_frame>
    <description>St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions</description>
  </secondary_outcome>
  <enrollment type="Actual">1232</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current&#xD;
        ATS/ERS guidelines)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Written informed consent for participation in the registry&#xD;
&#xD;
          -  Newly diagnosed (incident) or known (prevalent) IPF (based on diagnosis of treating&#xD;
             physician)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juergen Behr, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilian University (LMU) Munich, Med. Clinic V</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Pittrow, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Clinical Pharmacology, Medical Faculty, Technical University</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Pneumologie, Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V. Med. Clinic, Ludwig-Maximilians-Unviversity</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://insights-ipf.de</url>
    <description>Study website</description>
  </link>
  <reference>
    <citation>Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. [Characteristics and management of idiopathic pulmonary fibrosis: INSIGHTS-IPF registry]. Dtsch Med Wochenschr. 2012 Dec;137(49):2586-8. doi: 10.1055/s-0032-1327244. Epub 2012 Nov 27. German.</citation>
    <PMID>23188642</PMID>
  </reference>
  <reference>
    <citation>Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. Investigating significant health trends in idiopathic pulmonary fibrosis (INSIGHTS-IPF): rationale, aims and design of a nationwide prospective registry. BMJ Open Respir Res. 2014 Jan 3;1(1):e000010. doi: 10.1136/bmjresp-2013-000010. eCollection 2014. Erratum In: BMJ Open Respir Res. 2014;1(1):e000010corr1.</citation>
    <PMID>25478169</PMID>
  </reference>
  <results_reference>
    <citation>Behr J, Kreuter M, Hoeper MM, Wirtz H, Klotsche J, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Randerath W, Skowasch D, Meyer FJ, Kirschner J, Glaser S, Herth FJ, Welte T, Huber RM, Neurohr C, Schwaiblmair M, Kohlhaufl M, Hoffken G, Held M, Koch A, Bahmer T, Pittrow D. Management of patients with idiopathic pulmonary fibrosis in clinical practice: the INSIGHTS-IPF registry. Eur Respir J. 2015 Jul;46(1):186-96. doi: 10.1183/09031936.00217614. Epub 2015 Apr 2.</citation>
    <PMID>25837040</PMID>
  </results_reference>
  <results_reference>
    <citation>Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Herth FJF, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Frankenberger M, Behr J. Health related quality of life in patients with idiopathic pulmonary fibrosis in clinical practice: insights-IPF registry. Respir Res. 2017 Jul 14;18(1):139. doi: 10.1186/s12931-017-0621-y.</citation>
    <PMID>28709421</PMID>
  </results_reference>
  <results_reference>
    <citation>Leuschner G, Klotsche J, Kreuter M, Prasse A, Wirtz H, Pittrow D, Frankenberger M, Behr J, Kneidinger N; INSIGHTS-IPF Registry Group. Idiopathic Pulmonary Fibrosis in Elderly Patients: Analysis of the INSIGHTS-IPF Observational Study. Front Med (Lausanne). 2020 Nov 16;7:601279. doi: 10.3389/fmed.2020.601279. eCollection 2020.</citation>
    <PMID>33313046</PMID>
  </results_reference>
  <results_reference>
    <citation>Behr J, Prasse A, Wirtz H, Koschel D, Pittrow D, Held M, Klotsche J, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Kahn N, Welte T, Neurohr C, Schwaiblmair M, Bahmer T, Oqueka T, Frankenberger M, Kreuter M. Survival and course of lung function in the presence or absence of antifibrotic treatment in patients with idiopathic pulmonary fibrosis: long-term results of the INSIGHTS-IPF registry. Eur Respir J. 2020 Aug 13;56(2):1902279. doi: 10.1183/13993003.02279-2019. Print 2020 Aug.</citation>
    <PMID>32381492</PMID>
  </results_reference>
  <results_reference>
    <citation>Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Kahn N, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Oqueka T, Frankenberger M, Behr J. The clinical course of idiopathic pulmonary fibrosis and its association to quality of life over time: longitudinal data from the INSIGHTS-IPF registry. Respir Res. 2019 Mar 15;20(1):59. doi: 10.1186/s12931-019-1020-3.</citation>
    <PMID>30876420</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Treatment</keyword>
  <keyword>Treatment pathways</keyword>
  <keyword>Clinical routine</keyword>
  <keyword>Registry</keyword>
  <keyword>Outcomes</keyword>
  <keyword>Survival</keyword>
  <keyword>Patient-related outcomes</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Steroids</keyword>
  <keyword>Azathioprine</keyword>
  <keyword>N-Acetylcysteine</keyword>
  <keyword>Pirfenidone</keyword>
  <keyword>Tyrosine kinase inhibitors</keyword>
  <keyword>Nintedanib</keyword>
  <keyword>multicenter</keyword>
  <keyword>Germany</keyword>
  <keyword>Safety</keyword>
  <keyword>Adverse event</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01695408
org study id: INSIGHTS-IPF
nct id: NCT01695408
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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 model: Cohort
time perspective: Prospective
measure: Clinical course of IPF (in terms of symptoms, lung function, survival)
time frame: up to 5 years after inclusion
measure: Characteristics of patients with IPF
time frame: up to 5 years after inclusion
measure: Treatment pathways
time frame: up to 5 years after inclusion
measure: Functionality and quality of life
time frame: up to 5 years after inclusion
description: St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Juergen Behr, MD, PhD
role: Principal Investigator
affiliation: Ludwig-Maximilian University (LMU) Munich, Med. Clinic V
last name: David Pittrow, MD, PhD
role: Study Chair
affiliation: Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: http://insights-ipf.de
description: Study website
citation: Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. [Characteristics and management of idiopathic pulmonary fibrosis: INSIGHTS-IPF registry]. Dtsch Med Wochenschr. 2012 Dec;137(49):2586-8. doi: 10.1055/s-0032-1327244. Epub 2012 Nov 27. German.
PMID: 23188642
citation: Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. Investigating significant health trends in idiopathic pulmonary fibrosis (INSIGHTS-IPF): rationale, aims and design of a nationwide prospective registry. BMJ Open Respir Res. 2014 Jan 3;1(1):e000010. doi: 10.1136/bmjresp-2013-000010. eCollection 2014. Erratum In: BMJ Open Respir Res. 2014;1(1):e000010corr1.
PMID: 25478169
citation: Behr J, Kreuter M, Hoeper MM, Wirtz H, Klotsche J, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Randerath W, Skowasch D, Meyer FJ, Kirschner J, Glaser S, Herth FJ, Welte T, Huber RM, Neurohr C, Schwaiblmair M, Kohlhaufl M, Hoffken G, Held M, Koch A, Bahmer T, Pittrow D. Management of patients with idiopathic pulmonary fibrosis in clinical practice: the INSIGHTS-IPF registry. Eur Respir J. 2015 Jul;46(1):186-96. doi: 10.1183/09031936.00217614. Epub 2015 Apr 2.
PMID: 25837040
citation: Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Herth FJF, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Frankenberger M, Behr J. Health related quality of life in patients with idiopathic pulmonary fibrosis in clinical practice: insights-IPF registry. Respir Res. 2017 Jul 14;18(1):139. doi: 10.1186/s12931-017-0621-y.
PMID: 28709421
citation: Leuschner G, Klotsche J, Kreuter M, Prasse A, Wirtz H, Pittrow D, Frankenberger M, Behr J, Kneidinger N; INSIGHTS-IPF Registry Group. Idiopathic Pulmonary Fibrosis in Elderly Patients: Analysis of the INSIGHTS-IPF Observational Study. Front Med (Lausanne). 2020 Nov 16;7:601279. doi: 10.3389/fmed.2020.601279. eCollection 2020.
PMID: 33313046
citation: Behr J, Prasse A, Wirtz H, Koschel D, Pittrow D, Held M, Klotsche J, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Kahn N, Welte T, Neurohr C, Schwaiblmair M, Bahmer T, Oqueka T, Frankenberger M, Kreuter M. Survival and course of lung function in the presence or absence of antifibrotic treatment in patients with idiopathic pulmonary fibrosis: long-term results of the INSIGHTS-IPF registry. Eur Respir J. 2020 Aug 13;56(2):1902279. doi: 10.1183/13993003.02279-2019. Print 2020 Aug.
PMID: 32381492
citation: Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Kahn N, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Oqueka T, Frankenberger M, Behr J. The clinical course of idiopathic pulmonary fibrosis and its association to quality of life over time: longitudinal data from the INSIGHTS-IPF registry. Respir Res. 2019 Mar 15;20(1):59. doi: 10.1186/s12931-019-1020-3.
PMID: 30876420
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
sharing ipd: No