Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations - Trial NCT03449316

Timeline & Enrollment

Primary Outcome

Adverse events

Summary

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.

ICD-10 Classifications