{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:56:22Z","timestamp":1747184182112,"version":"3.40.5"},"reference-count":40,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T00:00:00Z","timestamp":1694131200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Several inefficiencies in drug development trial implementation may be improved by moving data collection from the clinic to mobile, allowing for more frequent measurements and therefore increased statistical power while aligning to a patient\u2010centric approach to trial design. Sensor\u2010based digital health technologies such as mobile spirometry (mSpirometry) are comparable to clinic spirometry for capturing outcomes, such as forced expiratory volume in 1\u2009s (FEV1); however, the impact of remote spirometry measurements on the detection of treatment effect has not been investigated. A protocol for a multicenter, single\u2010arm, open\u2010label interventional trial of long\u2010acting beta agonist (LABA) therapy among 60 participants with uncontrolled moderate asthma is described. Participants will complete twice\u2010daily mSpirometry at home and clinic spirometry during weekly visits, alongside continuous use of a wrist\u2010worn wearable and regular completion of several diaries capturing asthma symptoms as well as participant\u2010 and site\u2010reported satisfaction and ease of use of mSpirometry. The co\u2010primary objectives of this study are (A) to quantify the treatment effect of LABA therapy among participants with moderate asthma, using both clinical spirometry (FEV1<jats:sub>c<\/jats:sub>) and mSpirometry (FEV1<jats:sub>m<\/jats:sub>); and (B) to investigate whether FEV1<jats:sub>m<\/jats:sub> is as accurate as FEV1<jats:sub>c<\/jats:sub> in detecting the treatment effect using a mixed\u2010effect model for repeated measures. Study results will help inform whether the deployment of mSpirometry and a wrist\u2010worn wearable for remote data collection are feasible in a multicenter setting among participants with moderate asthma, which may then be generalizable to other populations with respiratory disease.<\/jats:p>","DOI":"10.1111\/cts.13615","type":"journal-article","created":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T14:04:44Z","timestamp":1692626684000},"page":"2112-2122","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Study protocol: A comparison of mobile and clinic\u2010based spirometry for capturing the treatment effect in moderate asthma"],"prefix":"10.1111","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7150-1748","authenticated-orcid":false,"given":"Elena S.","family":"Izmailova","sequence":"first","affiliation":[{"name":"Koneksa Health  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel","family":"Kilian","sequence":"additional","affiliation":[{"name":"Koneksa Health  New York New York USA"},{"name":"SSI Strategy  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessie P.","family":"Bakker","sequence":"additional","affiliation":[{"name":"Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"},{"name":"Department of Neurology Brigham and Women's Hospital  Boston Massachusetts USA"},{"name":"Division of Sleep Medicine Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shawna","family":"Evans","sequence":"additional","affiliation":[{"name":"Koneksa Health  New York New York USA"},{"name":"SSI Strategy  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1301-3209","authenticated-orcid":false,"given":"Anthony D.","family":"Scotina","sequence":"additional","affiliation":[{"name":"Koneksa Health  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theodore F.","family":"Reiss","sequence":"additional","affiliation":[{"name":"Independent Pharmaceutical Consultant  New Hope Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dave","family":"Singh","sequence":"additional","affiliation":[{"name":"Medicines Evaluation Unit, University of Manchester Manchester University NHS Foundation Trust  Manchester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0636-5006","authenticated-orcid":false,"given":"John A.","family":"Wagner","sequence":"additional","affiliation":[{"name":"Koneksa Health  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,9,8]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhealeco.2016.01.012"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2009.69"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-038863"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxv047"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12834"},{"key":"e_1_2_9_7_1","first-page":"267","article-title":"Diurnal variations in human pulmonary function","volume":"1","author":"Medarov BI","year":"2008","journal-title":"Int J Clin Exp Med"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.14024"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/s19112487"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2019.03.010"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/copd.S106142"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12931-022-02221-4"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2017.04.029"},{"key":"e_1_2_9_14_1","unstructured":"Montelukast sodium.Highlights of Prescribing Information. Accessed May 5 2023.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2012\/021409s036lbl.pdf"},{"key":"e_1_2_9_15_1","unstructured":"Dupilumab.Highlights of Prescribing Information. Accessed May 5 2023.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/761055lbl.pdf"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd4645"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12901"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1034\/j.1399-3003.1999.14d29.x"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD005307.pub2"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201908-1590ST"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2021.11.026"},{"key":"e_1_2_9_22_1","unstructured":"mSpiro device 510(k) clearance. Accessed May 5 2023.https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf15\/K150137.pdf"},{"key":"e_1_2_9_23_1","unstructured":"Embrace device 510(k) clearance. Accessed May 5 2023.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?ID=K181861"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD005076.pub2"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.3892\/etm.2011.268"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1159\/000500413"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-13-100"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s41030-018-0058-6"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.159.1.9804033"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40290-022-00458-4"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1200\/op.22.00702"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.2196\/34758"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.48325"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.5334\/aogh.2412"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.02.00283202"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.2196\/30791"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm9030706"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.22454\/PRiMER.2022.892688"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1200\/cci.22.00033"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcm.2016.02.012"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.15406\/ijbsbe.2018.04.00125"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13615","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,16]],"date-time":"2023-11-16T04:14:31Z","timestamp":1700108071000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.13615"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,8]]},"references-count":40,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1111\/cts.13615"],"URL":"https:\/\/doi.org\/10.1111\/cts.13615","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"type":"print","value":"1752-8054"},{"type":"electronic","value":"1752-8062"}],"subject":[],"published":{"date-parts":[[2023,9,8]]},"assertion":[{"value":"2023-05-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}