Clinical trial NCT01695408: Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis
Official title: Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Drug Treatment
Treatment pathways
Clinical routine
Registry
Outcomes
Survival
Patient-related outcomes
Quality of life
Steroids
Azathioprine
N-Acetylcysteine
Pirfenidone
Tyrosine kinase inhibitors
Nintedanib
multicenter
Germany
Safety
Adverse event
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: GWT-TUD GmbH
name: Boehringer Ingelheim
First posted: 2012-09-28
Enrollment: 1232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current ATS/ERS guidelines)

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.

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

Primary outcomes:
measure: Clinical course of IPF (in terms of symptoms, lung function, survival)
timeFrame: up to 5 years after inclusion
Secondary outcomes:
measure: Characteristics of patients with IPF
timeFrame: up to 5 years after inclusion
measure: Treatment pathways
timeFrame: up to 5 years after inclusion
measure: Functionality and quality of life
timeFrame: up to 5 years after inclusion
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Institute for Clinical Pharmacology, Medical Faculty, Technical University
city: Hannover
country: Germany
facility: Klinik für Pneumologie, Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum
city: Leipzig
country: Germany
facility: Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR
city: München
country: Germany
facility: V. Med. Clinic, Ludwig-Maximilians-Unviversity
Study officials:
affiliation: Ludwig-Maximilian University (LMU) Munich, Med. Clinic V
name: Juergen Behr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden
name: David Pittrow, MD, PhD
role: STUDY_CHAIR
References:
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: 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.
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: 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: 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: 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: 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.