A Phase 4 interventional study of Inhaler technique education in Asthma and COPD, sponsored by Aveiro-Aradas Family Health Unit. Status unknown. Open to participants aged 65 Years to 130 Years. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Aveiro-Aradas Family Health Unit · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
This group will receive a structured and regular follow-up plan, with education on inhaler technique. Patients will be trained by a Family Doctor (the primary investigator) in terms of the inhaler technique using placebo devices similar to their own devices. A teach-to-goal approach will be used, repeating all correct steps as many times as needed in order for patients to perform them correctly at each evaluation. There will be visits at baseline and after 3, 6 and 12 months to assess outcomes. In each visit, and prior to the main intervention with the primary investigator, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator.
Behavioral: Inhaler technique education
This group will receive usual care from their own Family doctors, with no specific intervention. Each doctor will perform the necessary consultations according to his real life judgment. Besides this, this group will perform visits at baseline and after 3, 6 and 12 months to assess secondary outcomes. At each visit, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator. At any appointment, if the patient asks for or if the clinician decides to teach inhaler technique, that will be recorded. If any adjustments are made in drug classes or device types in every participants, this information will be recorded.
Teaching of inhalers use with placebo devices in real training
Adverse events
This outcome will be quantifyed as "time to event" For Asthma, an event will be defined as increased respiratory clinical symptoms leading the patient to search for medical care, and resulting in any of the following: * Need for increased inhaled corticosteroid dose of at least 4x the regular dose * Need for increase of short-acting β2 agonists on a daily basis * Need for oral corticosteroids * Need for oral antibiotics * Hospitalization or Emergency Room (ER) visit with increased respiratory clinical symptoms. For COPD, an event will be defined as increased respiratory clinical symptoms inducing the patient to search for medical care, and resulting in any of the following: * Need for increase of long-acting β2 agonists on a daily basis * Need for oral corticosteroids * Need for oral antibiotics * Hospitalization or ER visit with increased respiratory clinical symptoms. Respiratory-related mortality and all-cause mortality will also be considered an adverse event.
Time frame: Evaluation at 12 months.
Clinical assessment
COPD Assessment Tools (CAT) \[scale from 0 (worst) to 40 (best) points\]
Time frame: Evaluation at 12 months
Clinical assessment
modified Medical Research Council (mMRC) \[scale from 0 (best) to 4 (worst) points\]
Time frame: Evaluation at 12 months
Clinical assessment
Control of Allergic Rhinitis and Asthma Test (CARAT) \[scale from 0 (worst) to 30 (best) points\]
Time frame: Evaluation at 12 months
Clinical assessment
Asthma Control Test (ACT) \[scale from 5 (worst) to 25 (best) points\]
Time frame: Evaluation at 12 months
Quality of Life
Asthma Quality of Life Questionnaire (AQLQ) \[scale from 32 (worst) to 224 (best) points\]
Time frame: Evaluation at 12 months.
Quality of Life
St. George's Respiratory Questionnaire \[scale from 0 (best) to 75 (worst) points\]
Time frame: Evaluation at 12 months.
Quality of Life
Clinical COPD Questionnaire (CCQ) \[scale from 0 (best) to 60 (worst) points\]
Time frame: Evaluation at 12 months.
Functional control
Functional control using FEV1 in liters.
Time frame: Evaluation at 12 months.
Functional control
Functional control using FVC in liters.
Time frame: Evaluation at 12 months.
Functional control
Functional control using PEF in liters/sec.
Time frame: Evaluation at 12 months.
Functional control
Functional control using MEF25-75, in % of predicted values.
Time frame: Evaluation at 12 months.
Functional control
Functional control using FEV1/FVC ratio.
Time frame: Evaluation at 12 months.
Adherence rate
Adherence rate using the Brief Medication Questionnaire \[scale from 0 (best) to 11 (worst) points\]
Time frame: Evaluation at 12 months.
Inhaler technique performance
Number of errors in inhaler technique (that will be standardized to a score up to 100% scale) \[To evaluate inhaler technique performance with each device, the Aerosol Drug Management Improvement Team (ADMIT) protocols and guidelines will be used, evaluating all the recommended steps for inhaler use on each one of them. For those devices that do not have any protocol from the ADMIT group, investigators will use the recommendations from the manufacture's Summary of Product Characteristics.
Time frame: Evaluation at 12 months.
No study locations are listed for this record.
Plan to share: Undecided — All data from the trial will be kept in a safe place of the principal investigator's institutional facilities and by the Data Safety Monitoring Board, in accordance with the national and international clinical research policies.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.