Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations
Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations
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.
Inclusion Criteria:

 -  Patients with a diagnosis of COPD or Asthma, medicated with any kind of inhaler device
 (pressurized Metered Dose Inhaler (pMDI) with or without Spacer, Dry Powder Inhaler
 (DPI) or Soft Mist), aged ≥65 years and being a regular user of primary health care
 services (defined as having at least one consultation performed in the last two years
 with his/her own Family Doctor). In order to minimize diagnostic inaccuracy, Asthma
 and COPD diagnosis will be reviewed in every participant at baseline prior to
 enrolment and according to GINA and GOLD strategies.

 Exclusion Criteria:

 -  Severe or acute illness (such as unstable cardiovascular status, unstable angina,
 recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of
 unknown origin, recent pneumothorax (within one month), recent thoracic, abdominal or
 eye surgery (within one month), acute nausea or vomiting, severe respiratory distress,
 dementia). Patients with intermittent asthma, as well as COPD patients with mild
 obstruction (GOLD class I) will be excluded, since these patients do not need to take
 inhaler medication on a daily basis, and tend to have a low frequency of disease
 exacerbations.