Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma
Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat®, as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety...
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| Veröffentlicht in: | Respiratory medicine 2019-08, Vol.155, p.58-60 |
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| creator | Graham, LeRoy M. Kerstjens, Huib A.M. Vogelberg, Christian Hamelmann, Eckard Szefler, Stanley J. Pisternick-Ruf, Wendelgard Engel, Michael El Azzi, Georges Unseld, Anna Foggs, Michael B. |
| description | Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat®, as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat®, compared with placebo, in black or African-American patients.
Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat® (5 μg or 2.5 μg). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1–75 years. The safety results of black or African-American patients were compared with the overall trial population.
Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population.
Tiotropium Respimat® appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma.
NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984.
•Tiotropium appears to be a safe add-on therapy for black patients with asthma.•The proportion reporting adverse events was similar to the overall population.•The placebo-controlled study included all age ranges and asthma severities. |
| doi_str_mv | 10.1016/j.rmed.2019.07.002 |
| format | Article |
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Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat® (5 μg or 2.5 μg). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1–75 years. The safety results of black or African-American patients were compared with the overall trial population.
Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population.
Tiotropium Respimat® appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma.
NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984.
•Tiotropium appears to be a safe add-on therapy for black patients with asthma.•The proportion reporting adverse events was similar to the overall population.•The placebo-controlled study included all age ranges and asthma severities.</description><identifier>ISSN: 0954-6111</identifier><identifier>EISSN: 1532-3064</identifier><identifier>DOI: 10.1016/j.rmed.2019.07.002</identifier><identifier>PMID: 31302579</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Administration, Inhalation ; Adolescent ; Adrenal Cortex Hormones - administration & dosage ; Adrenal Cortex Hormones - therapeutic use ; Adult ; Adults ; African Americans ; African Americans - ethnology ; Aged ; Asthma ; Asthma - diagnosis ; Asthma - drug therapy ; Asthma - ethnology ; Asthma - mortality ; Black or african american ; Bronchodilators ; Child ; Child, Preschool ; Cholinergic Antagonists - administration & dosage ; Cholinergic Antagonists - adverse effects ; Cholinergic Antagonists - therapeutic use ; Clinical trials ; Corticoids ; Corticosteroids ; Drug dosages ; Drug Therapy, Combination ; Humans ; Infant ; Lungs ; Middle Aged ; Minority & ethnic groups ; Morbidity ; Patients ; Pediatric ; Pediatrics ; Placebos - administration & dosage ; Population ; Respiratory function ; Safety ; Tiotropium ; Tiotropium Bromide - administration & dosage ; Tiotropium Bromide - adverse effects ; Tiotropium Bromide - therapeutic use ; Treatment Outcome ; Young Adult</subject><ispartof>Respiratory medicine, 2019-08, Vol.155, p.58-60</ispartof><rights>2019</rights><rights>Copyright © 2019. Published by Elsevier Ltd.</rights><rights>Copyright Elsevier Limited Aug 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-e2ef38abbde2038ee3dbfcc575663e59276470a2565d75264b4985d562dbcd013</citedby><cites>FETCH-LOGICAL-c428t-e2ef38abbde2038ee3dbfcc575663e59276470a2565d75264b4985d562dbcd013</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.rmed.2019.07.002$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31302579$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Graham, LeRoy M.</creatorcontrib><creatorcontrib>Kerstjens, Huib A.M.</creatorcontrib><creatorcontrib>Vogelberg, Christian</creatorcontrib><creatorcontrib>Hamelmann, Eckard</creatorcontrib><creatorcontrib>Szefler, Stanley J.</creatorcontrib><creatorcontrib>Pisternick-Ruf, Wendelgard</creatorcontrib><creatorcontrib>Engel, Michael</creatorcontrib><creatorcontrib>El Azzi, Georges</creatorcontrib><creatorcontrib>Unseld, Anna</creatorcontrib><creatorcontrib>Foggs, Michael B.</creatorcontrib><title>Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma</title><title>Respiratory medicine</title><addtitle>Respir Med</addtitle><description>Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat®, as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat®, compared with placebo, in black or African-American patients.
Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat® (5 μg or 2.5 μg). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1–75 years. The safety results of black or African-American patients were compared with the overall trial population.
Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population.
Tiotropium Respimat® appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma.
NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984.
•Tiotropium appears to be a safe add-on therapy for black patients with asthma.•The proportion reporting adverse events was similar to the overall population.•The placebo-controlled study included all age ranges and asthma severities.</description><subject>Administration, Inhalation</subject><subject>Adolescent</subject><subject>Adrenal Cortex Hormones - administration & dosage</subject><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Adult</subject><subject>Adults</subject><subject>African Americans</subject><subject>African Americans - ethnology</subject><subject>Aged</subject><subject>Asthma</subject><subject>Asthma - diagnosis</subject><subject>Asthma - drug therapy</subject><subject>Asthma - ethnology</subject><subject>Asthma - mortality</subject><subject>Black or african american</subject><subject>Bronchodilators</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Cholinergic Antagonists - administration & dosage</subject><subject>Cholinergic Antagonists - adverse effects</subject><subject>Cholinergic Antagonists - therapeutic use</subject><subject>Clinical trials</subject><subject>Corticoids</subject><subject>Corticosteroids</subject><subject>Drug dosages</subject><subject>Drug Therapy, Combination</subject><subject>Humans</subject><subject>Infant</subject><subject>Lungs</subject><subject>Middle Aged</subject><subject>Minority & ethnic groups</subject><subject>Morbidity</subject><subject>Patients</subject><subject>Pediatric</subject><subject>Pediatrics</subject><subject>Placebos - administration & dosage</subject><subject>Population</subject><subject>Respiratory function</subject><subject>Safety</subject><subject>Tiotropium</subject><subject>Tiotropium Bromide - administration & dosage</subject><subject>Tiotropium Bromide - adverse effects</subject><subject>Tiotropium Bromide - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0954-6111</issn><issn>1532-3064</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kM-KFDEQh4O4uOPqC3iQgBcv3VtJOulu8DIs_oMFYdWjhHRSzWac7rRJWpmX8iH2ycw4uxcPnqqgvt-P4iPkBYOaAVOXuzpO6GoOrK-hrQH4I7JhUvBKgGoekw30sqkUY-ycPE1pBwB908ATci6YAC7bfkO-fTYj5gMNI80-5BgWv070BtPiJ5PvflM_02Fv7HcaIt2O0VszV9sJ_y50MdnjnBP95fMtTYdpyaHEvKUm5dvJPCNno9knfH4_L8jXd2-_XH2orj-9_3i1va5sw7tcIcdRdGYYHHIQHaJww2itbKVSAmXPW9W0YLhU0rWSq2Zo-k46qbgbrAMmLsjrU-8Sw48VU9aTTxb3ezNjWJPmXHZMdtB3BX31D7oLa5zLd4VSrZBNJ2Sh-ImyMaQUcdRLLELiQTPQR_l6p4_y9VG-hlYX-SX08r56HY63h8iD7QK8OQFYXPz0GHWyxZ9F5yParF3w_-v_Az5sljI</recordid><startdate>201908</startdate><enddate>201908</enddate><creator>Graham, LeRoy M.</creator><creator>Kerstjens, Huib A.M.</creator><creator>Vogelberg, Christian</creator><creator>Hamelmann, Eckard</creator><creator>Szefler, Stanley J.</creator><creator>Pisternick-Ruf, Wendelgard</creator><creator>Engel, Michael</creator><creator>El Azzi, Georges</creator><creator>Unseld, Anna</creator><creator>Foggs, Michael B.</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U9</scope><scope>ASE</scope><scope>FPQ</scope><scope>H94</scope><scope>K6X</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>201908</creationdate><title>Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma</title><author>Graham, LeRoy M. ; Kerstjens, Huib A.M. ; Vogelberg, Christian ; Hamelmann, Eckard ; Szefler, Stanley J. ; Pisternick-Ruf, Wendelgard ; Engel, Michael ; El Azzi, Georges ; Unseld, Anna ; Foggs, Michael B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-e2ef38abbde2038ee3dbfcc575663e59276470a2565d75264b4985d562dbcd013</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Administration, Inhalation</topic><topic>Adolescent</topic><topic>Adrenal Cortex Hormones - administration & dosage</topic><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Adult</topic><topic>Adults</topic><topic>African Americans</topic><topic>African Americans - ethnology</topic><topic>Aged</topic><topic>Asthma</topic><topic>Asthma - diagnosis</topic><topic>Asthma - drug therapy</topic><topic>Asthma - ethnology</topic><topic>Asthma - mortality</topic><topic>Black or african american</topic><topic>Bronchodilators</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Cholinergic Antagonists - administration & dosage</topic><topic>Cholinergic Antagonists - adverse effects</topic><topic>Cholinergic Antagonists - therapeutic use</topic><topic>Clinical trials</topic><topic>Corticoids</topic><topic>Corticosteroids</topic><topic>Drug dosages</topic><topic>Drug Therapy, Combination</topic><topic>Humans</topic><topic>Infant</topic><topic>Lungs</topic><topic>Middle Aged</topic><topic>Minority & ethnic groups</topic><topic>Morbidity</topic><topic>Patients</topic><topic>Pediatric</topic><topic>Pediatrics</topic><topic>Placebos - administration & dosage</topic><topic>Population</topic><topic>Respiratory function</topic><topic>Safety</topic><topic>Tiotropium</topic><topic>Tiotropium Bromide - administration & dosage</topic><topic>Tiotropium Bromide - adverse effects</topic><topic>Tiotropium Bromide - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Graham, LeRoy M.</creatorcontrib><creatorcontrib>Kerstjens, Huib A.M.</creatorcontrib><creatorcontrib>Vogelberg, Christian</creatorcontrib><creatorcontrib>Hamelmann, Eckard</creatorcontrib><creatorcontrib>Szefler, Stanley J.</creatorcontrib><creatorcontrib>Pisternick-Ruf, Wendelgard</creatorcontrib><creatorcontrib>Engel, Michael</creatorcontrib><creatorcontrib>El Azzi, Georges</creatorcontrib><creatorcontrib>Unseld, Anna</creatorcontrib><creatorcontrib>Foggs, Michael B.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Virology and AIDS Abstracts</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Respiratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Graham, LeRoy M.</au><au>Kerstjens, Huib A.M.</au><au>Vogelberg, Christian</au><au>Hamelmann, Eckard</au><au>Szefler, Stanley J.</au><au>Pisternick-Ruf, Wendelgard</au><au>Engel, Michael</au><au>El Azzi, Georges</au><au>Unseld, Anna</au><au>Foggs, Michael B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma</atitle><jtitle>Respiratory medicine</jtitle><addtitle>Respir Med</addtitle><date>2019-08</date><risdate>2019</risdate><volume>155</volume><spage>58</spage><epage>60</epage><pages>58-60</pages><issn>0954-6111</issn><eissn>1532-3064</eissn><abstract>Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat®, as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat®, compared with placebo, in black or African-American patients.
Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat® (5 μg or 2.5 μg). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1–75 years. The safety results of black or African-American patients were compared with the overall trial population.
Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population.
Tiotropium Respimat® appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma.
NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984.
•Tiotropium appears to be a safe add-on therapy for black patients with asthma.•The proportion reporting adverse events was similar to the overall population.•The placebo-controlled study included all age ranges and asthma severities.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>31302579</pmid><doi>10.1016/j.rmed.2019.07.002</doi><tpages>3</tpages><oa>free_for_read</oa></addata></record> |
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| issn | 0954-6111 1532-3064 |
| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present); EZB-FREE-00999 freely available EZB journals |
| subjects | Administration, Inhalation Adolescent Adrenal Cortex Hormones - administration & dosage Adrenal Cortex Hormones - therapeutic use Adult Adults African Americans African Americans - ethnology Aged Asthma Asthma - diagnosis Asthma - drug therapy Asthma - ethnology Asthma - mortality Black or african american Bronchodilators Child Child, Preschool Cholinergic Antagonists - administration & dosage Cholinergic Antagonists - adverse effects Cholinergic Antagonists - therapeutic use Clinical trials Corticoids Corticosteroids Drug dosages Drug Therapy, Combination Humans Infant Lungs Middle Aged Minority & ethnic groups Morbidity Patients Pediatric Pediatrics Placebos - administration & dosage Population Respiratory function Safety Tiotropium Tiotropium Bromide - administration & dosage Tiotropium Bromide - adverse effects Tiotropium Bromide - therapeutic use Treatment Outcome Young Adult |
| title | Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma |
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