Clinical trial NCT03449316: Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
COPD
Keywords: Nebulizers and Vaporizers
Lead sponsor: Aveiro-Aradas Family Health Unit
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 146
Sex: ALL
Minimum age (years): 65
Maximum age (years): 130
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms single blinded randomised controlled trial with a 1 year follow up
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
timeFrame: Evaluation at 12 months.
Secondary outcomes:
measure: Clinical assessment
timeFrame: Evaluation at 12 months
measure: Clinical assessment
timeFrame: Evaluation at 12 months
measure: Clinical assessment
timeFrame: Evaluation at 12 months
measure: Clinical assessment
timeFrame: Evaluation at 12 months
measure: Quality of Life
timeFrame: Evaluation at 12 months.
measure: Quality of Life
timeFrame: Evaluation at 12 months.
measure: Quality of Life
timeFrame: Evaluation at 12 months.
measure: Functional control
timeFrame: Evaluation at 12 months.
measure: Functional control
timeFrame: Evaluation at 12 months.
measure: Functional control
timeFrame: Evaluation at 12 months.
measure: Functional control
timeFrame: Evaluation at 12 months.
measure: Functional control
timeFrame: Evaluation at 12 months.
measure: Adherence rate
timeFrame: Evaluation at 12 months.
measure: Inhaler technique performance
timeFrame: Evaluation at 12 months.
Other outcomes:
Locations:
Study officials:
References:
citation: Maricoto T, Correia-de-Sousa J, Taborda-Barata L. Inhaler technique education in elderly patients with asthma or COPD: impact on disease exacerbations-a protocol for a single-blinded randomised controlled trial. BMJ Open. 2019 Jan 28;9(1):e022685. doi: 10.1136/bmjopen-2018-022685.