Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 1:09 PM
Study NCT ID:
NCT01695408
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2012-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2012-09-26', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical course of IPF (in terms of symptoms, lung function, survival)', 'timeFrame': 'up to 5 years after inclusion'}], 'secondaryOutcomes': [{'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', 'description': 'St. Georges Respiratory Questionnaire; University of California Shortness of Breath Questionnaire; EuroQuol 5 dimensions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '23188642', 'type': 'BACKGROUND', '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': '25478169', 'type': 'BACKGROUND', '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.'}, {'pmid': '25837040', 'type': 'RESULT', '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': '28709421', 'type': 'RESULT', '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': '33313046', 'type': 'RESULT', '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': '32381492', 'type': 'RESULT', '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': '30876420', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://insights-ipf.de', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'INSIGHTS-IPF will report current and comprehensive data on Idiopathic Pulmonary Fibrosis (IPF) in the long-term.\n\nBaseline (cross-sectional part): Description of characteristics of IPF patients in terms of\n\n* key (socio-) demographic data\n* IPF risk factors, comorbidities\n* methods used for IPF diagnosis\n* IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values, biomarkers)\n* IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological treatment; listing and score for lung transplantation)\n* assessment of patient-related outcomes (PRO) such as quality of life\n\nFollow-up (prospectively up to at least 2 years after inclusion):\n\n* Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if available)\n* 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)\n* Patient-related outcomes such as quality of life, assessed once a year(for comparison with baseline)\n* Resource use for pharmacoeconomic analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current ATS/ERS guidelines)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Written informed consent for participation in the registry\n* Newly diagnosed (incident) or known (prevalent) IPF (based on diagnosis of treating physician)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01695408', 'acronym': 'INSIGHTS-IPF', 'briefTitle': 'Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Investigating Significant Health Trends in IPF (INSIGHTS-IPF). Nationwide Prospective Registry.', 'orgStudyIdInfo': {'id': 'INSIGHTS-IPF'}}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Institute for Clinical Pharmacology, Medical Faculty, Technical University', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Klinik für Pneumologie, Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Pneumologie und Beatmungsmedizin, Thoraxklinik,Universitätsklinikum', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Abteilung für Pneumologie Department Innere Medizin, Neurologie und Dermatologie Universitätsklinikum Leipzig AöR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'München', 'country': 'Germany', 'facility': 'V. Med. Clinic, Ludwig-Maximilians-Unviversity', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Juergen Behr, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig-Maximilian University (LMU) Munich, Med. Clinic V'}, {'name': 'David Pittrow, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'GWT-TUD GmbH', 'class': 'OTHER'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}