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A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

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研究单位: [1]Boehringer Ingelheim [2]University of Alabama at Birmingham,Birmingham,Alabama,United States,35233 [3]University of Southern California,Los Angeles,California,United States,90033 [4]Cedars-Sinai Medical Center,Los Angeles,California,United States,90048 [5]University of California Los Angeles,Los Angeles,California,United States,90095 [6]University of California Davis,Sacramento,California,United States,95817 [7]National Jewish Health,Denver,Colorado,United States,80206 [8]Yale University School of Medicine,New Haven,Connecticut,United States,06510 [9]Christiana Hospital,Newark,Delaware,United States,19718 [10]Georgetown University,Washington,District of Columbia,United States,20007 [11]St. Francis Medical Institute,Clearwater,Florida,United States,33765 [12]University of Florida Health Shands Hospital,Gainesville,Florida,United States,32610 [13]Clinical Research Specialists LLC,Kissimmee,Florida,United States,34746 [14]Advanced Pulmonary Research Institute,Loxahatchee Groves,Florida,United States,33470 [15]Destin Pulmonary Critical Care,Santa Rosa Beach,Florida,United States,32459 [16]Piedmont Healthcare,Atlanta,Georgia,United States,30309 [17]Evanston Hospital Pulmonary Clinic,Evanston,Illinois,United States,60201 [18]University of Kansas Medical Center,Kansas City,Kansas,United States,66160 [19]Louisville Pulmonary Care,Louisville,Kentucky,United States,40207 [20]Tulane University Hospital and Clinic,New Orleans,Louisiana,United States,70112 [21]Johns Hopkins Hospital,Baltimore,Maryland,United States,21224 [22]Massachusetts General Hospital,Boston,Massachusetts,United States,02114-2114 [23]Brigham and Women's Hospital,Boston,Massachusetts,United States,02115 [24]St. Elizabeth's Medical Center,Boston,Massachusetts,United States,02135 [25]Infinity Medical Research,North Dartmouth,Massachusetts,United States,02747 [26]University of Michigan Health System,Ann Arbor,Michigan,United States,48109-5314 [27]Beaumont Health,Royal Oak,Michigan,United States,48073 [28]Minnesota Lung Center and Sleep Institute,Edina,Minnesota,United States,55435 [29]University of Minnesota,Minneapolis,Minnesota,United States,55455 [30]Mayo Clinic, Rochester,Rochester,Minnesota,United States,55905 [31]The Lung Research Center, LLC,Chesterfield,Missouri,United States,63017 [32]Washington University School of Medicine,Saint Louis,Missouri,United States,63110 [33]Creighton University,Omaha,Nebraska,United States,68124 [34]University of Nebraska Medical Center,Omaha,Nebraska,United States,68198-1230 [35]Renown Regional Medical Center,Reno,Nevada,United States,89502 [36]Dartmouth-Hitchcock Medical Center,Lebanon,New Hampshire,United States,03756 [37]Stony Brook University Medical Center,Commack,New York,United States,11725 [38]Columbia University Medical Center-New York Presbyterian Hospital,New York,New York,United States,10032 [39]Weill Cornell Medicine,New York,New York,United States,10065 [40]Lenox Hill Hospital,New York,New York,United States,10075 [41]Duke University Medical Center,Durham,North Carolina,United States,27710 [42]Southeastern Research Center,Winston-Salem,North Carolina,United States,27103 [43]University of Cincinnati,Cincinnati,Ohio,United States,45267 [44]Cleveland Clinic,Cleveland,Ohio,United States,44195 [45]The Ohio State University Wexner Medical Center,Columbus,Ohio,United States,43210 [46]The Oregon Clinic,Portland,Oregon,United States,97220 [47]University of Pennsylvania,Philadelphia,Pennsylvania,United States,19104 [48]Thomas Jefferson University,Philadelphia,Pennsylvania,United States,19107 [49]Temple University Hospital,Philadelphia,Pennsylvania,United States,19140 [50]Allegheny General Hospital,Pittsburgh,Pennsylvania,United States,15212 [51]Infinity Medical Research, Inc.,East Providence,Rhode Island,United States,02914 [52]Lowcountry Lung and Critical Care,Charleston,South Carolina,United States,29406 [53]Clinical Trials Center of Middle Tennessee, LLC,Franklin,Tennessee,United States,37067 [54]Vanderbilt University Medical Center - Vanderbilt Lu

研究目的:
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

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