Asthma Clinical Trial
Official title:
Inhaler Technique Education in Elderly Patients With Asthma or COPD: Impact on Disease Exacerbations - a Protocol for a Single-blinded Randomised Controlled Trial
Introduction 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 RCT will be set, comparing a placebo-device
training programme versus usual care, with a one-year follow-up, in elderly patients 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
Chi-squared test will be used to study primary outcome and subgroup analysis will be carried
out according to major baseline characteristics.
Discussion The investigators expect to confirm that inhaler performance education will
significantly reduce exacerbation rate and improve clinical and functional control.
Ethics and dissemination:
Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to
evaluate data throughout the study and to monitor stop earlier criteria. Identity of all
participants will be protected. Results will be presented in scientific meeting and published
in peer-reviewed journals.
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