NCT01695408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

9.3 years

First QC Date

September 26, 2012

Last Update Submit

July 25, 2022

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Drug TreatmentTreatment pathwaysClinical routineRegistryOutcomesSurvivalPatient-related outcomesQuality of lifeSteroidsAzathioprineN-AcetylcysteinePirfenidoneTyrosine kinase inhibitorsNintedanibmulticenterGermanySafetyAdverse event

Outcome Measures

Primary Outcomes (1)

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

    up to 5 years after inclusion

Secondary Outcomes (3)

  • Characteristics of patients with IPF

    up to 5 years after inclusion

  • Treatment pathways

    up to 5 years after inclusion

  • Functionality and quality of life

    up to 5 years after inclusion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current ATS/ERS guidelines)

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institute for Clinical Pharmacology, Medical Faculty, Technical University

Dresden, 01307, Germany

Location

Klinik für Pneumologie, Medizinische Hochschule Hannover

Hanover, Germany

Location

Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum

Heidelberg, 69126, Germany

Location

Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR

Leipzig, Germany

Location

V. Med. Clinic, Ludwig-Maximilians-Unviversity

München, Germany

Location

Related Publications (7)

  • 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: 23188642BACKGROUND

  • 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.

    PMID: 25478169BACKGROUND

  • 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: 25837040RESULT

  • 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: 28709421RESULT

  • 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: 33313046RESULT

  • 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: 32381492RESULT

  • 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: 30876420RESULT

Related Links

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Juergen Behr, MD, PhD

    Ludwig-Maximilian University (LMU) Munich, Med. Clinic V

    PRINCIPAL INVESTIGATOR

  • David Pittrow, MD, PhD

    Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

October 1, 2012

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)