Registry for Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases - EXCITING

NCT02645968 | Completed

• 1 other identifier: ILD Patient Registry
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 22

Brief Summary

The purpose of this study is to collect valid data from all forms of health care on the incidence, prevalence, the regional distribution, characteristics, management and outcomes of different ILDs under clinical practice conditions.

Conditions

Interstitial Lung Disease (ILD)

Keywords

Pneumology; Registry; EXCITING; Interstitial lung disease; ILD

Outcome Measures

Primary Outcomes (1)

• Determination of characteristics, management and outcomes of patients with different ILDs under clinical practice conditions.

  1. (disease-related) characteristics of ILD patients 2. diagnostic procedures for the identification of ILDs 3. the clinical management of different (sub) types of ILD under clinical practice 4. the outcome of different types of ILDs and of ILD related therapies from all forms of health care facilities

  Six month interval over 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ILD patients from all forms of health care

You may qualify if:

• Signed informed consent
• Able to read and understand the scope and nature of data collection
• Aged ≥ 18 at time of informed consent
• Patients diagnosed with interstitial lung disease (ILD). Patients with suspicion on interstitial lung disease cannot be included into the registry, only after consens diagnosis of an ILD. This is also the case for patients with not classifiable ILDs.
• Subjects with the following subtypes of ILD will be enrolled:
• Idiopathic interstitial pneumonia (IIPs)
• Idiopathic pulmonary fibrosis (IPF)
• Non-specific interstitial pneumonia (NSIP)
• Desquamative interstitial pneumonia (DIP)
• Respiratory bronchiolitis-associated interstitial lung disease (RB-ILD)
• Cryptogenic organizing pneumonia (COP)
• Lymphocytic interstitial pneumonia (LIP)
• Acute interstitial pneumonia (AIP)
• Rare forms of IIPs (e.g. pleuropulmonary fibroelastosis)
• Not classifiable IIP

You may not qualify if:

• \- Patients without interstitial lung disease

Sponsors & Collaborators

• Heidelberg University: lead
• University of Giessen: collaborator
• German Center for Lung Research: collaborator
• Helmholtz Zentrum München: collaborator
• Institut für Lungenforschung e.V.: collaborator
• German Respiratory Society: collaborator
• WATL e.V.: collaborator
• Bundesverband der Pneumologen: collaborator
• Lungenfibrose e.V.: collaborator
• Sacura GmbH: collaborator
• Syneed Medidata GmbH: collaborator

Study Sites (22)

Lungenärztliche Gemeinschaftspraxis Dr. Storz / Dr. Prettner

Böblingen, Baden-Wurttemberg, 71034, Germany

Location

Thoraxklinik Heidelberg, Abteilung Pneumologie und Beatmungsmedizin

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Gesundheitsverbund Landeskreis Konstanz, Krankenhausbetriebsgesellschaft Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

Location

Pneumologische Praxis im Zentrum - PiZ, Dr. med. Hans-Paul Eulenbruch und Dr. med. Alexander Rupp

Stuttgart, Baden-Wurttemberg, 70173, Germany

Location

Klinikum Stuttgart, Klinik für Allgemeine Innere Medizin, Gastroenterologie, Hepatologie und Infektiologie, Pneumologie

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

Lungenpraxis Tübingen

Tübingen, Baden-Wurttemberg, 72072, Germany

Location

Pneumologisches Zentrum

Wiesloch, Baden-Wurttemberg, 69168, Germany

Location

Klinikverbund Kempten-Oberallgäu, Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin

Immenstadt im Allgäu, Bavaria, 87509, Germany

Location

Pneumologische Gemeinschaftspraxis Fulda Dres. Wiederhold, Schratz, Wissner

Fulda, Hesse, 36039, Germany

Location

Klinikum Fulda gAG, Medizinische Klinik V - Pneumologie

Fulda, Hesse, 36043, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II

Giessen, Hesse, 35392, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, Hesse, 34376, Germany

Location

Universitätsklinikum Aachen, Medizinische Klinik I

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Medizinisches Versorgungszentrum Malteser Bonn gem. GmbH, Malteser Lungen- und Allergiezentrum Bonn

Bonn, North Rhine-Westphalia, 53113, Germany

Location

St. Marien-Hospital GmbH

Cologne, North Rhine-Westphalia, 50668, Germany

Location

Malteser Krankenhaus St. Hildegardis, Klinik für Pneumologie und Beatmungsmedizin

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Johanniter-Krankenhaus Rheinhausen GmbH

Duisburg, North Rhine-Westphalia, 47228, Germany

Location

Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, North Rhine-Westphalia, 45239, Germany

Location

Klinkum Gütersloh, Medizinische Klink III, Pneumologie, Schlaf- und Beatmungsmedizin, Infektiologie und Allgemeine Innere Medizin

Gütersloh, North Rhine-Westphalia, 33332, Germany

Location

Katholische Kranken- und Pflegeeinrichtung Leverkusen GmbH, St. Remigius Krankenhaus Opladen

Leverkusen, North Rhine-Westphalia, 51379, Germany

Location

framol-med GmbH, Pneumoglische Gemeinschaftspraxis Rheine

Rheine, North Rhine-Westphalia, 48431, Germany

Location

Krankenhaus Bethanien gGmbH, Klinik für Pneumologie und Allergologie, Zentrum für Schlaf- und Beatmungsmedizin

Solingen, North Rhine-Westphalia, 42699, Germany

Location

Related Publications (16)

• Demedts M, Wells AU, Anto JM, Costabel U, Hubbard R, Cullinan P, Slabbynck H, Rizzato G, Poletti V, Verbeken EK, Thomeer MJ, Kokkarinen J, Dalphin JC, Taylor AN. Interstitial lung diseases: an epidemiological overview. Eur Respir J Suppl. 2001 Sep;32:2s-16s.

  PMID: 11816822 BACKGROUND

• Akgun KM, Crothers K, Pisani M. Epidemiology and management of common pulmonary diseases in older persons. J Gerontol A Biol Sci Med Sci. 2012 Mar;67(3):276-91. doi: 10.1093/gerona/glr251. Epub 2012 Feb 15.

  PMID: 22337938 BACKGROUND

• Ferreira JP, Almeida I, Marinho A, Cerveira C, Vasconcelos C. Anti-ro52 antibodies and interstitial lung disease in connective tissue diseases excluding scleroderma. ISRN Rheumatol. 2012;2012:415272. doi: 10.5402/2012/415272. Epub 2012 Mar 27.

  PMID: 22567412 BACKGROUND

• Gunnarsson R, Aalokken TM, Molberg O, Lund MB, Mynarek GK, Lexberg AS, Time K, Dhainaut AS, Bertelsen LT, Palm O, Irgens K, Becker-Merok A, Nordeide JL, Johnsen V, Pedersen S, Proven A, Garabet LS, Gran JT. Prevalence and severity of interstitial lung disease in mixed connective tissue disease: a nationwide, cross-sectional study. Ann Rheum Dis. 2012 Dec;71(12):1966-72. doi: 10.1136/annrheumdis-2011-201253. Epub 2012 May 1.

  PMID: 22550317 BACKGROUND

• Hallowell RW, Reed RM, Fraig M, Horton MR, Girgis RE. Severe pulmonary hypertension in idiopathic nonspecific interstitial pneumonia. Pulm Circ. 2012 Jan-Mar;2(1):101-6. doi: 10.4103/2045-8932.94842.

  PMID: 22558525 BACKGROUND

• Kobayashi A, Okamoto H. Treatment of interstitial lung diseases associated with connective tissue diseases. Expert Rev Clin Pharmacol. 2012 Mar;5(2):219-27. doi: 10.1586/ecp.12.9.

  PMID: 22390563 BACKGROUND

• Tzouvelekis A, Galanopoulos N, Bouros E, Kolios G, Zacharis G, Ntolios P, Koulelidis A, Oikonomou A, Bouros D. Effect and safety of mycophenolate mofetil or sodium in systemic sclerosis-associated interstitial lung disease: a meta-analysis. Pulm Med. 2012;2012:143637. doi: 10.1155/2012/143637. Epub 2012 May 10.

  PMID: 22655194 BACKGROUND

• Amar RK, Jick SS, Rosenberg D, Maher TM, Meier CR. Drug-/radiation-induced interstitial lung disease in the United Kingdom general population: incidence, all-cause mortality and characteristics at diagnosis. Respirology. 2012 Jul;17(5):861-8. doi: 10.1111/j.1440-1843.2012.02187.x.

  PMID: 22563933 BACKGROUND

• King TE Jr. Smoking and subclinical interstitial lung disease. N Engl J Med. 2011 Mar 10;364(10):968-70. doi: 10.1056/NEJMe1013966. No abstract available.

  PMID: 21388315 BACKGROUND

• Lederer DJ, Enright PL, Kawut SM, Hoffman EA, Hunninghake G, van Beek EJ, Austin JH, Jiang R, Lovasi GS, Barr RG. Cigarette smoking is associated with subclinical parenchymal lung disease: the Multi-Ethnic Study of Atherosclerosis (MESA)-lung study. Am J Respir Crit Care Med. 2009 Sep 1;180(5):407-14. doi: 10.1164/rccm.200812-1966OC. Epub 2009 Jun 19.

  PMID: 19542480 BACKGROUND

• Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

  PMID: 21471066 BACKGROUND

• Doyle TJ, Hunninghake GM, Rosas IO. Subclinical interstitial lung disease: why you should care. Am J Respir Crit Care Med. 2012 Jun 1;185(11):1147-53. doi: 10.1164/rccm.201108-1420PP. Epub 2012 Feb 23.

  PMID: 22366047 BACKGROUND

• Lynge E. Implication for epidemiology of disease registers. Public Health Rev. 1993-1994;21(3-4):263-70.

  PMID: 8047653 BACKGROUND

• American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.

  PMID: 11790668 BACKGROUND

• Demedts M, Costabel U. ATS/ERS international multidisciplinary consensus classification of the idiopathic interstitial pneumonias. Eur Respir J. 2002 May;19(5):794-6. doi: 10.1183/09031936.02.00492002. No abstract available.

  PMID: 12030715 BACKGROUND

• Kreuter M, Herth FJ, Wacker M, Leidl R, Hellmann A, Pfeifer M, Behr J, Witt S, Kauschka D, Mall M, Gunther A, Markart P. Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases: Rationale, Aims, and Design of a Nationwide Prospective Registry--The EXCITING-ILD Registry. Biomed Res Int. 2015;2015:123876. doi: 10.1155/2015/123876. Epub 2015 Nov 10.

  PMID: 26640781 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Kreuter, Prof. Dr.

  Centre for interstitial and rare lung diseases, Pneumology and Respiratory Medicine, Thorax Clinic, University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Center for interstitial and rare lung diseases

Study Record Dates

• First Submitted: December 28, 2015
• First Posted: January 5, 2016
• Study Start: May 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

DE (22)