{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T12:09:20Z","timestamp":1779192560002,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2016,2,9]],"date-time":"2016-02-09T00:00:00Z","timestamp":1454976000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2016,2,9]],"date-time":"2016-02-09T00:00:00Z","timestamp":1454976000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Aerosol Medicine and Pulmonary Drug Delivery"],"published-print":{"date-parts":[[2016,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      This study was conducted to confirm the 24-hour bronchodilator efficacy and pharmacokinetic profile of once-daily tiotropium Respimat\n                      <jats:sup>\u00ae<\/jats:sup>\n                      5\u2009\u03bcg add-on to inhaled corticosteroids (ICS) in adults with symptomatic asthma. It used a trial protocol designed to minimize the risk of pharmacokinetic sample contamination resulting from improper sampling procedure, sample handling, or device handling during priming and subsequent inhalation procedure.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A Phase II, randomized, double-blind, two-way crossover study (NCT01696071) comparing two daily dosing regimens of tiotropium for 4 weeks, once-daily 5\u2009\u03bcg (evening dosing) or twice-daily 2.5\u2009\u03bcg (morning and evening dosing), as add-on to maintenance therapy with ICS (400\u2013800\u2009\u03bcg budesonide or equivalent) as controller medication. There was no washout between treatment periods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>An increase in the area under the curve of the 24-hour forced expiratory volume in 1 second profile from study baseline was observed following once-daily tiotropium 5\u2009\u03bcg (217\u2009mL) and twice-daily 2.5\u2009\u03bcg (219\u2009mL), with no difference between the two regimens (\u22122\u2009mL [95% confidence interval: \u221238, 34]). In a subset of the study population, total tiotropium exposure, expressed as area under the plasma concentration versus time curve over 24 hours, was comparable between dosing regimens. Unexpected tiotropium plasma levels were observed in two patients, possibly because of contamination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The observed bronchodilator efficacy over 24 hours was similar with once-daily tiotropium 5\u2009\u03bcg and twice-daily 2.5\u2009\u03bcg as add-on to ICS therapy, supporting the suitability of once-daily dosing to provide sustained improvements in lung function in adults with symptomatic asthma.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jamp.2015.1260","type":"journal-article","created":{"date-parts":[[2016,2,9]],"date-time":"2016-02-09T11:50:40Z","timestamp":1455018640000},"page":"406-415","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":18,"title":["Pharmacodynamics and Pharmacokinetics Following Once-Daily and Twice-Daily Dosing of Tiotropium Respimat\n                    <sup>\u00ae<\/sup>\n                    in Asthma Using Standardized Sample-Contamination Avoidance"],"prefix":"10.1177","volume":"29","author":[{"given":"Kai-Michael","family":"Beeh","sequence":"first","affiliation":[{"name":"Insaf Institut f\u00fcr Atemwegsforschung GmbH","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne-Marie","family":"Kirsten","sequence":"additional","affiliation":[{"name":"German Center for Lung Research","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Dusser","sequence":"additional","affiliation":[{"name":"Cochin Hospital","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashish","family":"Sharma","sequence":"additional","affiliation":[{"name":"Translational Medicine and Clinical Pharmacology","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piet","family":"Cornelissen","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH & Co. KG","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ralf","family":"Sigmund","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH & Co. KG","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Petra","family":"Moroni-Zentgraf","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH & Co. KG","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald","family":"Dahl","sequence":"additional","affiliation":[{"name":"Odense University Hospital","place":["Denmark"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2016,2,9]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200401-033OC"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1183\/09059180.00001209"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.4104\/pcrj.2011.00056"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2012.01.039"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1378\/chest.130.1_suppl.4S"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.3109\/02770900903184237"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.3109\/02770903.2011.654022"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1208606"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(15)00031-4"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2014.12.005"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.4155\/bio.14.50"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2005.00796.x"},{"key":"e_1_3_3_14_2","first-page":"597","article-title":"Multi-centre observational study of spurious hyperkalaemia due to EDTA contamination","volume":"56","author":"Cornes MP","year":"2010","unstructured":"Cornes MP, , Davidson F, , Darwin L, , Gay C, , Redpath M, , Waldron JL, , Ford C, , and Gama R: Multi-centre observational study of spurious hyperkalaemia due to EDTA contamination. Clin Lab. 2010; 56:597\u2013599.","journal-title":"Clin Lab"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1R543"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2006.07.006"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.3109\/03639049809089953"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1208\/s12249-012-9765-8"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2008.10.002"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2012.03.007"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1042\/cs0690251"}],"container-title":["Journal of Aerosol Medicine and Pulmonary Drug Delivery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/jamp.2015.1260","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jamp.2015.1260","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jamp.2015.1260","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T11:46:23Z","timestamp":1779191183000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/jamp.2015.1260"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,2,9]]},"references-count":20,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2016,10,1]]}},"alternative-id":["10.1089\/jamp.2015.1260"],"URL":"https:\/\/doi.org\/10.1089\/jamp.2015.1260","relation":{},"ISSN":["1941-2711","1941-2703"],"issn-type":[{"value":"1941-2711","type":"print"},{"value":"1941-2703","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,2,9]]}}}