Interstitial Lung Disease (ILD)EXCITINGNCT02645968
Registry for Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases - EXCITING
An observational study of Interstitial Lung Disease (ILD), run by Heidelberg University at 22 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- How many people
- 600 participants
- Where
- 22 sitesGermany
- Study dates
- May 2014to May 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ILD patients from all forms of health care
Who may be able to join
- 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)
Show all 44Show fewer
- 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
- Granulomatous lung disease
- Sarcoidosis
- Berylliosis
- Other (e.g. involvement in chronic inflammatory liver and gut diseases, except EAA)
- Hypersensitivity pneumonitis (exogen allergic alveolitis (EAA))
- Farmer's lung
- Bird keepers' lung disease
- Origin unknown
- Other
- Rheumatic and connective tissue diseases with pulmonary involvement like:
- Connective tissue disease (subtype)
- Vasculitis
- Rheumatoid arthritis
- Pneumoconiosis
- Asbestosis
- Silicosis
- Other
- Other forms
- Pulmonary lymphangioleiomyomatosis
- Pulmonary Langerhans' cell histiocytosis
- Pulmonary alveolar proteinosis
- Eosinophilic pneumonia
- Post-ARDS Fibrosis
- Drug-related
- Radiotherapy associated
- Fibrosis in emphysema patients without signs of other ILDs (i.e. smoking related interstitial fibrosis or "emphysemasclerosis")
- Others
- Not classifiable
- Furthermore for each subtype it will be queried, if a diagnosis of concomitant emphysema in ILD was made.
Who cannot join
- Patients without interstitial lung disease
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Germany22 sites
Universitätsklinikum Aachen, Medizinische Klinik I
Aachen, North Rhine-Westphalia, 52074
Lungenärztliche Gemeinschaftspraxis Dr. Storz / Dr. Prettner
Böblingen, Baden-Wurttemberg, 71034
Medizinisches Versorgungszentrum Malteser Bonn gem. GmbH, Malteser Lungen- und Allergiezentrum Bonn
Bonn, North Rhine-Westphalia, 53113
St. Marien-Hospital GmbH
Cologne, North Rhine-Westphalia, 50668
Malteser Krankenhaus St. Hildegardis, Klinik für Pneumologie und Beatmungsmedizin
Cologne, North Rhine-Westphalia, 50931
Johanniter-Krankenhaus Rheinhausen GmbH
Duisburg, North Rhine-Westphalia, 47228
Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, North Rhine-Westphalia, 45239
Pneumologische Gemeinschaftspraxis Fulda Dres. Wiederhold, Schratz, Wissner
Fulda, Hesse, 36039
Klinikum Fulda gAG, Medizinische Klinik V - Pneumologie
Fulda, Hesse, 36043
Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik und Poliklinik II
Giessen, Hesse, 35392
Klinkum Gütersloh, Medizinische Klink III, Pneumologie, Schlaf- und Beatmungsmedizin, Infektiologie und Allgemeine Innere Medizin
Gütersloh, North Rhine-Westphalia, 33332
Thoraxklinik Heidelberg, Abteilung Pneumologie und Beatmungsmedizin
Heidelberg, Baden-Wurttemberg, 69126
Lungenfachklinik Immenhausen
Immenhausen, Hesse, 34376
Klinikverbund Kempten-Oberallgäu, Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin
Immenstadt im Allgäu, Bavaria, 87509
Gesundheitsverbund Landeskreis Konstanz, Krankenhausbetriebsgesellschaft Konstanz
Konstanz, Baden-Wurttemberg, 78464
Katholische Kranken- und Pflegeeinrichtung Leverkusen GmbH, St. Remigius Krankenhaus Opladen
Leverkusen, North Rhine-Westphalia, 51379
framol-med GmbH, Pneumoglische Gemeinschaftspraxis Rheine
Rheine, North Rhine-Westphalia, 48431
Krankenhaus Bethanien gGmbH, Klinik für Pneumologie und Allergologie, Zentrum für Schlaf- und Beatmungsmedizin
Solingen, North Rhine-Westphalia, 42699
Pneumologische Praxis im Zentrum - PiZ, Dr. med. Hans-Paul Eulenbruch und Dr. med. Alexander Rupp
Stuttgart, Baden-Wurttemberg, 70173
Klinikum Stuttgart, Klinik für Allgemeine Innere Medizin, Gastroenterologie, Hepatologie und Infektiologie, Pneumologie
Stuttgart, Baden-Wurttemberg, 70174
Lungenpraxis Tübingen
Tübingen, Baden-Wurttemberg, 72072
Pneumologisches Zentrum
Wiesloch, Baden-Wurttemberg, 69168
About this study
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.
Read the detailed description
Interstitial lung diseases (ILD) are a heterogeneous group of more than 200 entities that can be idiopathic or as a result of other diseases and/or treatments. All forms of ILD are considered to be seldom or very seldom (and most of them are so-called "orphan" diseases), in their entirety they seem to represent an epidemiological burden, which should not be underestimated, e.g. as "normal" symptoms of the elderly.
The knowledge about the epidemiology of ILDs is very limited, in general and in Germany in particular. For Germany no current, valid and comprehensive population-based data on ILDs exist because no appropriate ILD classification was available for a long time. The epidemiological data, which were collected before the introduction of the current classification of ILD according to the ATS/ERS consensus and before HRCT was considered the diagnostic gold standard, are not very reliable. Furthermore systemic investigations relating to the development of an ILD of risk groups, such as patients undergoing radio- or chemotherapy or patients with connective tissue disease, are restricted.
Thus, only little is known about costs associated with ILDs. Idiopathic Pulmonary Fibrosis (IPF), as one of the disease entities, was shown to be associated with high healthcare utilization and costs in England and the USA, as in many cases lung transplantation is the only therapeutic option and also new pharmaceutical treatments are costly. But there is a lack of data on healthcare utilization and financial consequences of other ILD than IPF in Germany. Therefore, this registry will provide an important database for health economics and health services research questions.
Against this background, this multi-centre, non interventional prospective observational disease and outcomes registry for ILD aims 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. In detail, demographic data such as gender, age, country of birth, place of residence; disease related data such as subtype of ILD, treatment center, diagnostic procedures (e.g. HRCT, lung biopsy, pulmonary function tests); risk factors (e.g. smoking status, profession, familial ILD); co-morbidities; ILD management as analysed by the kind and frequency of pharmacological and non-pharmacological therapies; outcome; and consumption of resources will be recorded. Therefore, this registry will allow obtaining a comprehensive and current epidemiologic report for ILDs in Germany and can be particularly helpful in uncovering correlations between risk exposure and disease development.
This study, with up to 100 sites, initially focused on the federal states Baden-Wuerttemberg and Hesse, is planned for a minimum of 5 years and 600 patients should be enrolled as part of the study a screening/baseline visit, on which the Informed Consent Form will be signed, and every 6 months regularly updates/phone contacts will be performed.
Following quality procedures are applicable for this registry:
- Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
- Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
- Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
- Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
- Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
- Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- Pneumology, Registry, EXCITING, Interstitial lung disease, ILD
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of characteristics, management and outcomes of patients with different ILDs under clinical practice conditions.
- (disease-related) characteristics of ILD patients
- diagnostic procedures for the identification of ILDs
- the clinical management of different (sub) types of ILD under clinical practice
- the outcome of different types of ILDs and of ILD related therapies from all forms of health care facilities
Measured: Six month interval over 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMay 2014
- Primary completionApr 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen, German Center for Lung Research, Helmholtz Zentrum München, Institut für Lungenforschung e.V., German Respiratory Society, WATL e.V., Bundesverband der Pneumologen, Lungenfibrose e.V., Sacura GmbH, Syneed Medidata GmbH
- Responsible party
- Principal investigator, Michael Kreuter, Heidelberg University
- Investigators
- Michael Kreuter, Prof. Dr., Principal investigator, Centre for interstitial and rare lung diseases, Pneumology and Respiratory Medicine, Thorax Clinic, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645968
- Sponsor's protocol ID
- ILD Patient Registry
- Acronym
- EXCITING
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2015
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11816822Akgun 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.
PubMed 22337938Ferreira 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.
PubMed 22567412Gunnarsson 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.
PubMed 22550317Hallowell 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.
PubMed 22558525Kobayashi 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.
PubMed 22390563Tzouvelekis 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.
PubMed 22655194Amar 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.
PubMed 22563933King 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.
PubMed 21388315Lederer 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.
PubMed 19542480Raghu 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.
PubMed 21471066Doyle 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.
PubMed 22366047Lynge E. Implication for epidemiology of disease registers. Public Health Rev. 1993-1994;21(3-4):263-70.
PubMed 8047653American 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.
PubMed 11790668Demedts 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.
PubMed 12030715
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases - EXCITING
- ClinicalTrials.gov ID
- NCT02645968
- Acronym / sponsor ID
- EXCITING / ILD Patient Registry
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- Pneumology, Registry, EXCITING, Interstitial lung disease, ILD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University of Giessen, German Center for Lung Research, Helmholtz Zentrum München, Institut für Lungenforschung e.V., German Respiratory Society, WATL e.V., Bundesverband der Pneumologen, Lungenfibrose e.V., Sacura GmbH, Syneed Medidata GmbH
- Study start
- May 2014
- Primary completion
- Apr 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interstitial lung diseases (ILD) are a heterogeneous group of more than 200 entities that can be idiopathic or as a result of other diseases and/or treatments. All forms of ILD are considered to be seldom or very seldom (and most of them are so-called "orphan" diseases), in their entirety they seem to represent an epidemiological burden, which should not be underestimated, e.g. as "normal" symptoms of the elderly.
The knowledge about the epidemiology of ILDs is very limited, in general and in Germany in particular. For Germany no current, valid and comprehensive population-based data on ILDs exist because no appropriate ILD classification was available for a long time. The epidemiological data, which were collected before the introduction of the current classification of ILD according to the ATS/ERS consensus and before HRCT was considered the diagnostic gold standard, are not very reliable. Furthermore systemic investigations relating to the development of an ILD of risk groups, such as patients undergoing radio- or chemotherapy or patients with connective tissue disease, are restricted.
Thus, only little is known about costs associated with ILDs. Idiopathic Pulmonary Fibrosis (IPF), as one of the disease entities, was shown to be associated with high healthcare utilization and costs in England and the USA, as in many cases lung transplantation is the only therapeutic option and also new pharmaceutical treatments are costly. But there is a lack of data on healthcare utilization and financial consequences of other ILD than IPF in Germany. Therefore, this registry will provide an important database for health economics and health services research questions.
Against this background, this multi-centre, non interventional prospective observational disease and outcomes registry for ILD aims 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. In detail, demographic data such as gender, age, country of birth, place of residence; disease related data such as subtype of ILD, treatment center, diagnostic procedures (e.g. HRCT, lung biopsy, pulmonary function tests); risk factors (e.g. smoking status, profession, familial ILD); co-morbidities; ILD management as analysed by the kind and frequency of pharmacological and non-pharmacological therapies; outcome; and consumption of resources will be recorded. Therefore, this registry will allow obtaining a comprehensive and current epidemiologic report for ILDs in Germany and can be particularly helpful in uncovering correlations between risk exposure and disease development.
This study, with up to 100 sites, initially focused on the federal states Baden-Wuerttemberg and Hesse, is planned for a minimum of 5 years and 600 patients should be enrolled as part of the study a screening/baseline visit, on which the Informed Consent Form will be signed, and every 6 months regularly updates/phone contacts will be performed.
Following quality procedures are applicable for this registry:
- Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
- Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
- Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
- Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
- Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
- Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
- Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ILD patients from all forms of health care
Key inclusion criteria (44 listed)
- 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.
- Idiopathic interstitial pneumonia (IIPs)
Key exclusion criteria (1 listed)
- Patients without interstitial lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of characteristics, management and outcomes of patients with different ILDs under clinical practice conditions.
Time frame: Six month interval over 5 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Background: PubMed 11816822Demedts 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.
- Background: PubMed 22337938Akgun 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.
- Background: PubMed 22567412Ferreira 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.
- Background: PubMed 22550317Gunnarsson 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.
- Background: PubMed 22558525Hallowell 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.
- Background: PubMed 22390563Kobayashi 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.
- Background: PubMed 22655194Tzouvelekis 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.
- Background: PubMed 22563933Amar 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.
- Background: PubMed 21388315King 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.
- Background: PubMed 19542480Lederer 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.
- Background: PubMed 21471066Raghu 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.
- Background: PubMed 22366047Doyle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kreuter, Prof. Dr. principal investigator
Centre for interstitial and rare lung diseases, Pneumology and Respiratory Medicine, Thorax Clinic, University Hospital Heidelberg
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease (ILD), run by Heidelberg University at 22 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 44 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of characteristics, management and outcomes of patients with different ILDs under clinical practice conditions. (time frame: Six month interval over 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645968, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.