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Abstract
Introduction 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.
Methods and analysis 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 χ² test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.
Ethics and dissemination 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-2017–025. Results will be presented in scientific meetings and published in peer-reviewed journals.
Trial registration number NCT03449316; Pre-Results.
- chronic obstructive pulmonary disease
- asthma
- nebulizers and vaporizers
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Footnotes
Contributors All authors have equally contributed to the elaboration of this protocol in every stage of its design and writing. TM elaborated the first draft of the study, JC-d-S and LT-B gave inputs to all necessary design adjustments, and all authors have carried out final revisions of the manuscript.
Funding This work was developed without any funding support or financial source. The academic affiliation of this protocol is the the Faculty of Health Sciences at the University of Beira Interior and Life and Health Sciences Research Institute (ICVS)/3B’s at University of Minho in Portugal. This work was prepared with scientific support from Harvard Medical School, in accordance with the Portuguese Clinical Scholarship Research Training Program.
Competing interests JC-d-S reports competing interests from Harvard Medical School, during the conduct of the study, as scientific support. He also reports from Boheringer Ingelheim and from AstraZeneca outside the submitted work, and all these fees were received by a non-profit organisation to be used in CME and research. The remaining authors declare only from Harvard Medical School, during the conduct of the study, as scientific support.
Patient consent Not required.
Ethics approval Ethics Committee of University of Beira Interior, Covilhã, Portugal.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data from the trial will be kept in a safe place of the principal investigator’s institutional facilities and by the Data Safety Monitoring Board, in accordance with the national and international clinical research policies.