{"id":"https://openalex.org/W4289780819","doi":"https://doi.org/10.1183/23120541.00240-2022","title":"Phase I studies of BI 1015550, a preferential phosphodiesterase 4B inhibitor, in healthy males and patients with idiopathic pulmonary fibrosis","display_name":"Phase I studies of BI 1015550, a preferential phosphodiesterase 4B inhibitor, in healthy males and patients with idiopathic pulmonary fibrosis","publication_year":2022,"publication_date":"2022-08-04","ids":{"openalex":"https://openalex.org/W4289780819","doi":"https://doi.org/10.1183/23120541.00240-2022","pmid":"https://pubmed.ncbi.nlm.nih.gov/36299369","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/9589333"},"language":"en","primary_location":{"id":"doi:10.1183/23120541.00240-2022","doi":"https://doi.org/10.1183/23120541.00240-2022","is_oa":true,"landing_page_url":"https://doi.org/10.1183/23120541.00240-2022","pdf_url":"https://openres.ersjournals.com/content/erjor/8/4/00240-2022.full.pdf","source":{"id":"https://openalex.org/S2738738902","display_name":"ERJ Open Research","issn_l":"2312-0541","issn":["2312-0541"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","norway-1","oarl","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310317833","host_organization_name":"European Respiratory Society","host_organization_lineage":["https://openalex.org/P4310317833"],"host_organization_lineage_names":["European Respiratory Society"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"ERJ Open Research","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://openres.ersjournals.com/content/erjor/8/4/00240-2022.full.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5058325633","display_name":"Toby M. Maher","orcid":"https://orcid.org/0000-0001-7192-9149","observed_orcids":["https://orcid.org/0000-0001-7192-9149"]},"institutions":[{"id":"https://openalex.org/I1174212","display_name":"University of Southern California","ror":"https://ror.org/03taz7m60","country_code":"US","type":"education","lineage":["https://openalex.org/I1174212"]},{"id":"https://openalex.org/I47508984","display_name":"Imperial College London","ror":"https://ror.org/041kmwe10","country_code":"GB","type":"education","lineage":["https://openalex.org/I47508984"]}],"countries":["GB","US"],"is_corresponding":true,"raw_author_name":"Toby M. Maher","raw_affiliation_strings":["Inflammation, Repair, and Development Section, National Heart and Lung Institute, Imperial College London, London, UK","Keck Medicine of USC, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Inflammation, Repair, and Development Section, National Heart and Lung Institute, Imperial College London, London, UK","institution_ids":["https://openalex.org/I47508984"]},{"raw_affiliation_string":"Keck Medicine of USC, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I1174212"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5080432773","display_name":"Christina Schlecker","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1330995197","display_name":"Boehringer Ingelheim (Germany)","ror":"https://ror.org/00q32j219","country_code":"DE","type":"company","lineage":["https://openalex.org/I1330995197"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Christina Schlecker","raw_affiliation_strings":["Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany","institution_ids":["https://openalex.org/I1330995197"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076096793","display_name":"Doreen Luedtke","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1330995197","display_name":"Boehringer Ingelheim (Germany)","ror":"https://ror.org/00q32j219","country_code":"DE","type":"company","lineage":["https://openalex.org/I1330995197"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Doreen Luedtke","raw_affiliation_strings":["Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany","institution_ids":["https://openalex.org/I1330995197"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5029080361","display_name":"Sebastian Bossert","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1330995197","display_name":"Boehringer Ingelheim (Germany)","ror":"https://ror.org/00q32j219","country_code":"DE","type":"company","lineage":["https://openalex.org/I1330995197"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Sebastian Bossert","raw_affiliation_strings":["Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany","institution_ids":["https://openalex.org/I1330995197"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075075363","display_name":"Donald F. Zoz","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210160255","display_name":"Boehringer Ingelheim (United States)","ror":"https://ror.org/05kffp613","country_code":"US","type":"company","lineage":["https://openalex.org/I1330995197","https://openalex.org/I4210160255"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Donald F. Zoz","raw_affiliation_strings":["Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA","institution_ids":["https://openalex.org/I4210160255"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5110177836","display_name":"Armin Schultz","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210103903","display_name":"Clinical Research Services","ror":"https://ror.org/01c127k53","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210103903"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Armin Schultz","raw_affiliation_strings":["CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany","institution_ids":["https://openalex.org/I4210103903"]}]}],"institutions":[],"countries_distinct_count":3,"institutions_distinct_count":5,"corresponding_author_ids":["https://openalex.org/A5058325633"],"corresponding_institution_ids":["https://openalex.org/I1174212","https://openalex.org/I47508984"],"apc_list":{"value":750,"currency":"EUR","value_usd":808},"apc_paid":{"value":750,"currency":"EUR","value_usd":808},"fwci":3.5351,"has_fulltext":true,"cited_by_count":29,"citation_normalized_percentile":{"value":0.9427839,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":97,"max":99},"biblio":{"volume":"8","issue":"4","first_page":"00240","last_page":"2022"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10870","display_name":"Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis","score":0.8564000129699707,"subfield":{"id":"https://openalex.org/subfields/2740","display_name":"Pulmonary and Respiratory Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10870","display_name":"Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis","score":0.8564000129699707,"subfield":{"id":"https://openalex.org/subfields/2740","display_name":"Pulmonary and Respiratory Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12434","display_name":"Phosphodiesterase function and regulation","score":0.10459999740123749,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10728","display_name":"Pulmonary Hypertension Research and Treatments","score":0.0027000000700354576,"subfield":{"id":"https://openalex.org/subfields/2740","display_name":"Pulmonary and Respiratory Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/idiopathic-pulmonary-fibrosis","display_name":"idiopathic pulmonary fibrosis","score":0.9240000247955322},{"id":"https://openalex.org/keywords/antifibrotic-therapy","display_name":"antifibrotic therapy","score":0.9229999780654907},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.6039999723434448},{"id":"https://openalex.org/keywords/tolerability","display_name":"tolerability","score":0.9670000076293945},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.9940000176429749},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.7940000295639038},{"id":"https://openalex.org/keywords/headache","display_name":"headache","score":0.7940000295639038},{"id":"https://openalex.org/keywords/gastrointestinal-side-effects","display_name":"gastrointestinal adverse effects","score":0.8830000162124634},{"id":"https://openalex.org/keywords/healthy-volunteers","display_name":"healthy volunteers","score":0.46399998664855957}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9402436017990112},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.8628890514373779},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.840981662273407},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6944648027420044},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.6297957301139832},{"id":"https://openalex.org/C2778341716","wikidata":"https://www.wikidata.org/wiki/Q2290446","display_name":"Idiopathic pulmonary fibrosis","level":3,"score":0.6293691396713257},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.4966893792152405},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.4927566349506378},{"id":"https://openalex.org/C31760486","wikidata":"https://www.wikidata.org/wiki/Q7180990","display_name":"Phases of clinical research","level":3,"score":0.4550853371620178},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.4355434775352478},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.431001752614975},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.2483707070350647},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.15415775775909424},{"id":"https://openalex.org/C2777714996","wikidata":"https://www.wikidata.org/wiki/Q7886","display_name":"Lung","level":2,"score":0.15049615502357483},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0}],"mesh":[],"locations_count":5,"locations":[{"id":"doi:10.1183/23120541.00240-2022","doi":"https://doi.org/10.1183/23120541.00240-2022","is_oa":true,"landing_page_url":"https://doi.org/10.1183/23120541.00240-2022","pdf_url":"https://openres.ersjournals.com/content/erjor/8/4/00240-2022.full.pdf","source":{"id":"https://openalex.org/S2738738902","display_name":"ERJ Open Research","issn_l":"2312-0541","issn":["2312-0541"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","norway-1","oarl","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310317833","host_organization_name":"European Respiratory Society","host_organization_lineage":["https://openalex.org/P4310317833"],"host_organization_lineage_names":["European Respiratory Society"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"ERJ Open Research","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:9589333","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/9589333","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"ERJ Open Res","raw_type":"Text"},{"id":"pmid:36299369","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/36299369","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"ERJ open research","raw_type":"Journal Article"},{"id":"pmh:oai:doaj.org/article:21b9b0816508498c90339a882a036afe","doi":null,"is_oa":false,"landing_page_url":"https://doaj.org/article/21b9b0816508498c90339a882a036afe","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"ERJ Open Research, Vol 8, Iss 4 (2022)","raw_type":"article"},{"id":"pmh:oai:spiral.imperial.ac.uk:10044/1/100466","doi":null,"is_oa":true,"landing_page_url":"http://hdl.handle.net/10044/1/100466","pdf_url":null,"source":{"id":"https://openalex.org/S4306401396","display_name":"Spiral (Imperial College London)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I47508984","host_organization_name":"Imperial College London","host_organization_lineage":["https://openalex.org/I47508984"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1183/23120541.00240-2022","doi":"https://doi.org/10.1183/23120541.00240-2022","is_oa":true,"landing_page_url":"https://doi.org/10.1183/23120541.00240-2022","pdf_url":"https://openres.ersjournals.com/content/erjor/8/4/00240-2022.full.pdf","source":{"id":"https://openalex.org/S2738738902","display_name":"ERJ Open Research","issn_l":"2312-0541","issn":["2312-0541"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","norway-1","oarl","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310317833","host_organization_name":"European Respiratory Society","host_organization_lineage":["https://openalex.org/P4310317833"],"host_organization_lineage_names":["European Respiratory Society"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"ERJ Open Research","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":1.0}],"study_designs":[{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[{"id":"https://openalex.org/G664983364","display_name":"Improving clinical phenotyping of interstitial lung disease for better diagnosis and disease management","funder_award_id":"CS-2013-13-017","funder_id":"https://openalex.org/F4320319990","funder_display_name":"National Institute for Health and Care Research"}],"funders":[{"id":"https://openalex.org/F4320306257","display_name":"Boehringer Ingelheim","ror":"https://ror.org/05kffp613"},{"id":"https://openalex.org/F4320319990","display_name":"National Institute for Health and Care Research","ror":"https://ror.org/0187kwz08"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4289780819.pdf","grobid_xml":"https://content.openalex.org/works/W4289780819.grobid-xml"},"referenced_works_count":14,"referenced_works":["https://openalex.org/W2026501434","https://openalex.org/W2117488044","https://openalex.org/W2129892102","https://openalex.org/W2167383172","https://openalex.org/W2362254035","https://openalex.org/W2810048175","https://openalex.org/W2897406695","https://openalex.org/W2911246644","https://openalex.org/W3006532268","https://openalex.org/W3012514064","https://openalex.org/W3081472252","https://openalex.org/W3155881139","https://openalex.org/W4280599153","https://openalex.org/W4281771694"],"related_works":["https://openalex.org/W4327934567","https://openalex.org/W4280599153","https://openalex.org/W4317889300","https://openalex.org/W4386003218","https://openalex.org/W4415018411","https://openalex.org/W4310828486","https://openalex.org/W4281771694","https://openalex.org/W4327934586","https://openalex.org/W4316040298","https://openalex.org/W4225309520"],"abstract_inverted_index":{"Introduction:":[0],"BI":[1,28,56,98,147,169,208,228],"1015550":[2,29,57,99,170,229],"is":[3],"a":[4,143],"phosphodiesterase":[5],"4":[6],"(PDE4)":[7],"inhibitor":[8],"that":[9],"has":[10],"antifibrotic":[11],"properties.":[12],"Phase":[13,128,195],"I":[14,45,129],"and":[15,25,34,65,75,171,239,241],"Ic":[16,86,196],"studies":[17],"were":[18,49,92,133,161,183,188,200,224],"conducted":[19],"to":[20,52,94,106],"investigate":[21],"the":[22,43,84,112,116,127,194],"safety,":[23],"tolerability":[24],"pharmacokinetics":[26],"of":[27,62,72,118,137,146,165,204,213],"in":[30,58,202,235,249],"healthy":[31,138,236],"male":[32,139,237,240],"subjects":[33,48,119,140,238],"patients":[35,89,205,243],"with":[36,90,120,142,150,168,207,211,244],"idiopathic":[37],"pulmonary":[38],"fibrosis":[39],"(IPF).":[40],"Methods:":[41],"In":[42,83,126,193],"phase":[44,85],"study,":[46,87,130,197],"42":[47],"partially":[50],"randomised":[51,93],"receive":[53,95],"placebo":[54,101],"or":[55,68,100],"single":[59,144],"rising":[60,70],"doses":[61,71],"36":[63],"mg":[64,74,77,97],"48":[66],"mg,":[67],"multiple":[69,157],"6":[73],"12":[76,107],"twice":[78,102],"daily":[79,103],"over":[80],"14":[81],"days.":[82],"15":[88],"IPF":[91],"18":[96],"for":[104,135,163],"up":[105],"weeks.":[108],"For":[109,154],"both":[110],"studies,":[111],"primary":[113],"endpoint":[114],"was":[115],"number":[117],"drug-related":[121,131,159,198],"adverse":[122],"events":[123],"(AEs).":[124],"Results:":[125],"AEs":[132,160,179,199,220],"reported":[134,162,178,201],"50.0%":[136],"treated":[141,167,206],"dose":[145],"1015550,":[148,209],"compared":[149,210],"16.7%":[151],"receiving":[152,156,173,215],"placebo.":[153,174,216],"those":[155,166,214],"doses,":[158],"37.5%":[164],"12.5%":[172],"The":[175,217],"most":[176,218],"frequently":[177],"by":[180,191,221],"organ":[181,222],"class":[182,223],"nervous":[184],"system":[185],"disorders,":[186],"which":[187],"largely":[189],"driven":[190],"headache.":[192],"90.0%":[203],"60.0%":[212],"frequent":[219],"gastrointestinal":[225],"AEs.":[226],"Conclusions:":[227],"had":[230],"an":[231],"acceptable":[232],"safety":[233],"profile":[234],"female":[242],"IPF,":[245],"supporting":[246],"further":[247],"development":[248],"larger":[250],"trials.":[251]},"counts_by_year":[{"year":2026,"cited_by_count":7},{"year":2025,"cited_by_count":11},{"year":2024,"cited_by_count":6},{"year":2023,"cited_by_count":5}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2022-08-04T00:00:00"}
