{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T02:27:03Z","timestamp":1773282423814,"version":"3.50.1"},"reference-count":62,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,11,20]]},"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Chronic Obstructive Pulmonary Disease (COPD)and asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A multicentre single-blinded Randomised Controlled Trial (RCT) will be set up, comparing an inhaler education programme with a teach-to-goal placebo-device training versus usual care, with a 1-year follow-up, in patients above 65 years of age with asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions \u03c7\u00b2 test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Every participant will sign a written consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor early stopping criteria. Identity of all participants will be protected. This protocol was approved on 22 November 2017 by the local Ethics Committee of University of Beira Interior, with the reference number CE-UBI-Pj-2017\u2013025. Results will be presented in scientific meetings and published in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03449316\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT03449316<\/jats:ext-link>\n                      ; Pre-Results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-022685","type":"journal-article","created":{"date-parts":[[2019,1,29]],"date-time":"2019-01-29T05:45:51Z","timestamp":1548740751000},"page":"e022685","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Inhaler technique education in elderly patients with asthma or COPD: impact on disease exacerbations\u2014a protocol for a single-blinded randomised controlled trial"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03449316","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Tiago","family":"Maricoto","sequence":"first","affiliation":[{"name":"Aveiro-Aradas Family Health Unit, Aveiro Health Centre, Aveiro, Portugal"},{"name":"Faculty of Health Sciences, University of Beira Interior, Covilh\u00e3, Portugal"}]},{"given":"Jaime","family":"Correia-de-Sousa","sequence":"additional","affiliation":[{"name":"Life and Health Sciences Research Institute (ICVS)\/3B\u2019s\u2014PT Government Associate Laboratory, University of Minho, Braga, Portugal"},{"name":"Horizonte Family Health Unit, Matosinhos Health Centre, Matosinhos, Portugal"}]},{"given":"Lu\u00eds","family":"Taborda-Barata","sequence":"additional","affiliation":[{"name":"CICS\u2014Health Sciences Research Centre; NuESA\u2014Environment & Health Study Group, Faculty of Health Sciences, University of Beira Interior, Covilha, Portugal"},{"name":"Department of Allergy & Clinical Immunology, Cova da Beira University Hospital Centre, Covilh\u00e3, Portugal"}]}],"member":"239","published-online":{"date-parts":[[2019,1,28]]},"reference":[{"key":"2025121408524555000_9.1.e022685.1","unstructured":"World Health Organization. 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