{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T15:30:44Z","timestamp":1777908644929,"version":"3.51.4"},"reference-count":16,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2019,5,24]],"date-time":"2019-05-24T00:00:00Z","timestamp":1558656000000},"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":[[2019,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>As non-cystic fibrosis bronchiectasis (NCFB) progresses, patients suffer irreversible lung damage and deterioration in lung function. This study explored whether inhalational parameters (peak inspiratory flow [PIF, primary endpoint], inspiratory volume and time [secondary endpoints]) represent barriers to complete dosing in patients with poor lung function who are using Ciprofloxacin dry powder for inhalation (DPI) (a drug\u2013device combination of the T-326 inhaler device and a Ciprofloxacin dry powder formulation).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This open-label, multicenter study generated inspiratory flow rate data from patients with NCFB using the breath-actuated T-326 dry powder inhaler. These rates were compared against reference values to identify whether patients with all degrees of lung function impairment could generate sufficient flow rates to facilitate adequate drug delivery. Patients attended screening and a second visit 1\u2009\u2212\u200914 days later. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1\/FVC, and inspiratory capacity were measured via spirometry at both visits. Forty-two patients were screened for inclusion; 33 met eligibility criteria and were stratified into one of three groups based on their FEV1% predicted value (group 1: 25% \u2264 FEV1% predicted &lt;45%; group 2: 45% \u2264 FEV1% predicted &lt;70%; group 3: FEV1% predicted \u226570%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>No significant between-group differences occurred in PIF (mean flow rates 68.21, 66.01, and 65.18\u2009L\/min in groups 1, 2, and 3, respectively). Individual minimum PIFs of 46.0\u201349.0\u2009L\/min were observed across groups. These results all exceeded the reference value (minimum PIF 45\u2009L\/min for Ciprofloxacin DPI) indicating that regardless of the level of airflow obstruction, patients were capable of achieving sufficient PIFs to aerosolize and inhale Ciprofloxacin dry powder with the T-326 inhaler.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Our data indicate that T-326 is suitable for use in the drug\u2013device combination Ciprofloxacin DPI to provide targeted pulmonary delivery in patients with NCFB, including those with significantly impaired lung function.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jamp.2018.1464","type":"journal-article","created":{"date-parts":[[2019,3,8]],"date-time":"2019-03-08T11:32:31Z","timestamp":1552044751000},"page":"156-163","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Ciprofloxacin Dry Powder for Inhalation: Inspiratory Flow in Patients with Non-cystic Fibrosis Bronchiectasis"],"prefix":"10.1177","volume":"32","author":[{"given":"Heino","family":"Stass","sequence":"first","affiliation":[{"name":"Department of Research &amp; Development, Clinical PK CV, Bayer AG, Wuppertal, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes","family":"Nagelschmitz","sequence":"additional","affiliation":[{"name":"Department of Research &amp; Development, Clinical PK CV, Bayer AG, Wuppertal, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dominik","family":"Kappeler","sequence":"additional","affiliation":[{"name":"Department of Clinical Operations, Inamed GmbH, Gauting, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Knut","family":"Sommerer","sequence":"additional","affiliation":[{"name":"Department of Clinical Operations, Inamed GmbH, Gauting, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Astrid","family":"Patzlaff","sequence":"additional","affiliation":[{"name":"Department of Clinical Operations, Inamed GmbH, Gauting, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Boris","family":"Weimann","sequence":"additional","affiliation":[{"name":"Chrestos Concept GmbH &amp; Co. KG, Essen, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2019,5,24]]},"reference":[{"key":"e_1_3_3_2_2","first-page":"131","article-title":"Inhalation drug delivery devices: technology update","volume":"8","author":"Ibrahim M","year":"2015","unstructured":"Ibrahim M, , Verma R, , and Garcia-Contreras L: Inhalation drug delivery devices: technology update. Med Devices (Auckl). 2015; 8:131\u2013139.","journal-title":"Med Devices (Auckl)"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2014.04.004"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.2174\/1874306401408010008"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1089\/jam.2006.19.456"},{"key":"e_1_3_3_6_2","doi-asserted-by":"crossref","first-page":"1103","DOI":"10.1513\/AnnalsATS.201702-156PS","article-title":"Peak inspiratory flow rate as a criterion for dry powder inhaler use in chronic obstructive pulmonary disease","volume":"14","author":"Mahler DA","year":"2017","unstructured":"Mahler DA: Peak inspiratory flow rate as a criterion for dry powder inhaler use in chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2017; 14:1103\u20131107.","journal-title":"Ann Am Thorac Soc"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1089\/jamp.2013.1119"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pupt.2018.03.005"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1089\/jamp.2015.1282"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.05.00034805"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1183\/09041950.005s1693"},{"key":"e_1_3_3_12_2","first-page":"A24","volume-title":"J Aerosol Med Pulm Drug Deliv 27","volume":"4","author":"Prentner S","unstructured":"Prentner S, , Kietzig C, , Schulte M, , and Sommerer K: System to perform flow profile measurements with inhalation devices while used by human volunteers. [Abstract]. Presented at The Aerosol Society Drug Delivery to the Lungs 24 International Conference, Edinburgh, United Kingdom, December 11\u201313, 2013; J Aerosol Med Pulm Drug Deliv 27:4:A24; DOI:10.1089\/jamp.2014.ab01.abstracts"},{"key":"e_1_3_3_13_2","unstructured":"Swedish Medical Products Agency: Public Assessment Report 2013. Salmeterol\/Fluticasone Hexal 50 microgram\/500 microgram inhalation powder. Available from: https:\/\/docetp.mpa.se\/LMF\/Salmeterol-Fluticasone%20Hexal%20inhalation%20powder %20pre-dispensed%20ENG%20PAR_09001be68046a210.pdf (Accessed on February21 2019)."},{"key":"e_1_3_3_14_2","unstructured":"Medicines and Healthcare Products Regulatory Agency (MHRA) Public Assessment Report 2015: Lifsar and Tritenva 50\u2009mg\/500 microgram per metered dose inhalation powder. 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