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Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations

NCT03449316 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2018-02-28

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Inhaler technique education

Teaching of inhalers use with placebo devices in real training

Sponsors & Collaborators

  • Aveiro-Aradas Family Health Unit

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-31
Completion
2019-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449316 on ClinicalTrials.gov