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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1337-1080 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) | |
| 2026-526028-38 | Registry Identifier | CTIS |
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This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse.
Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression.
Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerandomilast arm | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerandomilast | Drug | Nerandomilast |
| |
| Placebo matching nerandomilast |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52 | at baseline, at week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in total disease extent (TDE [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52 | at baseline, at week 52 | |
| Absolute change from baseline in reticulovascular score (RVS [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52 |
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Inclusion criteria :
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| Drug |
Placebo matching nerandomilast |
|
| at baseline, at week 52 |
| Absolute change from baseline in FVC (% predicted) at Week 52 | at baseline, at week 52 |
| Time to development of incident progressive pulmonary fibrosis (PPF) (as assessed and documented by investigator) or death over the duration of the trial | up to 28 months |
| Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial | up to 28 months |
| Time to relative decline from baseline in FVC (% predicted) of >10% or death over the duration of the trial | up to 28 months |
| Absolute change from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) at Week 52 | at baseline, at week 52 |
| Time to absolute decline from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) of >10% or death over the duration of the trial | up to 28 months |
| University of Southern California | Los Angeles | California | 90033 | United States |
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| Newport Native MD, Inc | Newport Beach | California | 92663 | United States |
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| Clinical Research Specialists LLC - Kissimmee | Kissimmee | Florida | 34746 | United States |
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| Lakeland Regional Medical Center - Lakeland | Lakeland | Florida | 33805 | United States |
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| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470 | United States |
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| Avanza Medical Research Center | Pensacola | Florida | 32503 | United States |
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| Coastal Pulmonary & Critical Care | St. Petersburg | Florida | 33704 | United States |
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| Indiana University Health Enterprise Clinical Research Operation | Indianapolis | Indiana | 46202 | United States |
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| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| Weill Cornell Medicine-New York-60569 | New York | New York | 10021 | United States |
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| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | United States |
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| Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine | New Bern | North Carolina | 28562 | United States |
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| Southeastern Research Center-Winston-Salem-61365 | Winston-Salem | North Carolina | 27103 | United States |
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| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
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| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | United States |
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| Clinical Trials Center of Middle Tennessee, LLC | Franklin | Tennessee | 37067 | United States |
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| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
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| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | United States |
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| Instituto de Medicina Respiratoria (IMeR) | Alberdi Sur | X5003DCE | Argentina |
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| Hospital Aleman | CABA | 1118 | Argentina |
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| Fundacion NIBA Neurologia Infantil Buenos Aires | CABA | 1182 | Argentina |
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| Consultorios Médicos del Buen Ayre | Capital Federal | 1425 | Argentina |
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| Instituto Ave Pulmo - Fundacion Enfisema | Mar del Plata | 7600 | Argentina |
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| INSARES | Mendoza | M5500CCG | Argentina |
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| Fundacion Innovaciencia | Rosario | 2000 | Argentina |
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| Medical University of Graz | Graz | 8036 | Austria |
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| Hospital Elisabethinen Linz | Linz | 4020 | Austria |
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| Johannes Kepler University Linz | Linz | 4020 | Austria |
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| Wiener Gesundheitsverbund | Vienna | 1140 | Austria |
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| Wiener Gesundheitsverbund | Vienna | 1210 | Austria |
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| UZ Leuven | Leuven | 3000 | Belgium |
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| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
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| AZ Delta | Roeselare | 8800 | Belgium |
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| CLARE - Clinica de Pneumologia | Goiânia | 74110-030 | Brazil |
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| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | 90050-170 | Brazil |
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| IMIP Pernambuco | Recife | 50070902 | Brazil |
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| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
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| INCOR e Hospital das Clínicas da Universidade de São Paulo | São Paulo | 05403-000 | Brazil |
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| Synergy Respiratory Care | Sherwood Park | Alberta | T8H 0N2 | Canada |
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| Kelowna Respirology & Allergy Research | Kelowna | British Columbia | V1Y 3H5 | Canada |
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| St. Paul's Hospital (Vancouver) | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
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| CIC Mauricie (Trois Rivieres) | Trois-Rivières | Quebec | G8T 7A1 | Canada |
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| Beijing Chao-Yang Hospital | Beijing | 100020 | China |
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| The Second Xiangya Hospital Of Central South University | Changsha | 410011 | China |
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| West China Hospital, Sichuan University | Chengdu | 610041 | China |
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| People's Hospital of Sichuan Province | Chengdu | 610072 | China |
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| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510000 | China |
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| Zhejiang Hospital | Hangzhou | 310013 | China |
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| Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | 310016 | China |
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| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
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| Shanghai Chest Hospital | Shanghai | 200030 | China |
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| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
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| The First Affiliated Hospital of Soochow University | Suzhou | 215006 | China |
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| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
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| Wuhan Union Hospital | Wuhan | 430022 | China |
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| Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T | Wuhan | 430030 | China |
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| Wuxi People's Hospital | Wuxi | 214043 | China |
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| Second Affiliated Hospital of Xi'an JiaoTong University | Xi'an | 710004 | China |
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| General Hospital of Ningxia Medical University | Yinchuan | 750004 | China |
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| Henan Provincial People's Hospital | Zhengzhou | 450003 | China |
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| HYKS Keuhkosairauksien tutkimusyksikkö | Helsinki | 000290 | Finland |
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| Oulun yliopistollinen keskussairaala | Oulu | 90220 | Finland |
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| Turku University Hospital / TYKS | Turku | 20521 | Finland |
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| HOP d'Angers | Angers | 49933 | France |
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| HOP Avicenne | Bobigny | 93000 | France |
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| Hôpital Louis Pradel | Bron | 69677 | France |
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| HOP CHU Caen | Caen | 14033 | France |
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| HOP CHU de Grenoble | La Tronche | 38700 | France |
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| INS Coeur Poumon | Lille | 59037 | France |
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| HOP Nord | Marseille | 13015 | France |
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| Hopital Pasteur | Nice | 06000 | France |
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| HOP Bichat | Paris | 75018 | France |
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| HOP Pontchaillou | Rennes | 35033 | France |
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| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
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| Vivantes Netzwerk für Gesundheit GmbH | Berlin | 12351 | Germany |
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| Universitätsklinikum Bonn AöR | Bonn | 53127 | Germany |
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| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | 45239 | Germany |
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| Klinikum Region Hannover GmbH | Hanover | 30459 | Germany |
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| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
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| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
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| Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
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| Klinikum der Universität München AÖR | München | 81377 | Germany |
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| Robert Bosch Gesellschaft für medizinische Forschung mbH | Stuttgart | 70376 | Germany |
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| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania | Catania | 95124 | Italy |
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| Ospedale Colonnello D Avanzo | Foggia | 71100 | Italy |
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| Ospedale G.B. Morgagni | Forlì | 47121 | Italy |
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| Ospedale Classificato San Giuseppe | Milan | 20123 | Italy |
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| A.O. San Gerardo di Monza | Monza | 20900 | Italy |
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| Azienda Ospedaliera Universitaria di Padova | Padova | 35128 | Italy |
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| Pol. Universitario Tor Vergata | Roma | 00133 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | 00168 | Italy |
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| Tosei General Hospital | Aichi, Seto | 489-8642 | Japan |
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| National Hospital Organization Kyushu Medical Center | Fukuoka, Fukuoka | 810-8563 | Japan |
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| Hospital of the University of Occupational and Environmental Health | Fukuoka, Kitakyushu | 807-8556 | Japan |
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| Hiroshima Prefectural Hospital | Hiroshima, Hiroshima | 734-8530 | Japan |
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| Hiroshima University Hospital | Hiroshima, Hiroshima | 734-8551 | Japan |
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| Sapporo Medical University Hospital | Hokkaido, Sapporo | 060-8543 | Japan |
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| Kagawa University Hospital | Kagawa, Kita-gun | 761-0793 | Japan |
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| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | 236-0051 | Japan |
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| Kindai University Hospital | Osaka, Sakai | 590-0197 | Japan |
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| National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | 591-8555 | Japan |
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| Hamamatsu University Hospital | Shizuoka, Hamamatsu | 431-3192 | Japan |
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| Tokushima University Hospital | Tokushima, Tokushima | 770-8503 | Japan |
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| Juntendo University Hospital | Tokyo, Bunkyo-ku | 113-8431 | Japan |
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| Keio University Hospital | Tokyo, Shinjuku-ku | 160-8582 | Japan |
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| National Center for Global Health and Medicine | Tokyo, Shinjuku-ku | 162-8655 | Japan |
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| Centro de Investigacion Integral MEDIVEST S.C | Chihuahua City | 31203 | Mexico |
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| Centro de Investigacion Farmacologica del Bajío, S.C. | León | 37160 | Mexico |
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| Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | 64460 | Mexico |
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| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
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| Erasmus Medisch Centrum | Rotterdam | 3015 GD | Netherlands |
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| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
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| Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu | Poznan | 60-569 | Poland |
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| Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o. | Świdnik | 21-040 | Poland |
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| National Institute Of Tuberculosis And Lung Diseases | Warsaw | 01-138 | Poland |
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| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji | Warsaw | 02-637 | Poland |
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| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
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| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
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| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
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| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| Asan Medical Center | Seoul | 05505 | South Korea |
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| Samsung Medical Center | Seoul | 06351 | South Korea |
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| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
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| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
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| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
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| Hospital de Galdakao | Galdakao | 48960 | Spain |
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| Hospital General de Granollers | Granollers | 08402 | Spain |
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| Hospital Universitari de Bellvitge | Hospitalet Llobregat | 08907 | Spain |
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| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
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| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
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| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
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| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
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| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
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| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
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| China Medical University Hospital | Taichung | 404 | Taiwan |
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| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
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| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
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| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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