AsthmaPhase 4NCT03449316
Inhaler Technique in Elderly Patients: Impact on Disease Exacerbations
A Phase 4 study testing Inhaler technique education in people with Asthma and COPD, run by Aveiro-Aradas Family Health Unit.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 130 years
- What is being tested?
- Inhaler technique education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 130 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read more
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.
- Being tested
- Inhaler technique education
- Keywords
- Nebulizers and Vaporizers
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaler technique educationBehavioural
Teaching of inhalers use with placebo devices in real training
| Study group | Role | What they receive |
|---|---|---|
| Inhaler technique education | Experimental | 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. Receives: Behavioral: Inhaler technique education |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluation at 12 months.
Secondary outcomes (14)
Clinical assessment
COPD Assessment Tools (CAT) [scale from 0 (worst) to 40 (best) points]
Measured: Evaluation at 12 months
Clinical assessment
modified Medical Research Council (mMRC) [scale from 0 (best) to 4 (worst) points]
Measured: Evaluation at 12 months
Clinical assessment
Control of Allergic Rhinitis and Asthma Test (CARAT) [scale from 0 (worst) to 30 (best) points]
Measured: Evaluation at 12 months
Clinical assessment
Asthma Control Test (ACT) [scale from 5 (worst) to 25 (best) points]
Measured: Evaluation at 12 months
Quality of Life
Asthma Quality of Life Questionnaire (AQLQ) [scale from 32 (worst) to 224 (best) points]
Measured: Evaluation at 12 months.
Quality of Life
St. George's Respiratory Questionnaire [scale from 0 (best) to 75 (worst) points]
Measured: Evaluation at 12 months.
Quality of Life
Clinical COPD Questionnaire (CCQ) [scale from 0 (best) to 60 (worst) points]
Measured: Evaluation at 12 months.
Functional control
Functional control using FEV1 in liters.
Measured: Evaluation at 12 months.
Functional control
Functional control using FVC in liters.
Measured: Evaluation at 12 months.
Functional control
Functional control using PEF in liters/sec.
Measured: Evaluation at 12 months.
Functional control
Functional control using MEF25-75, in % of predicted values.
Measured: Evaluation at 12 months.
Functional control
Functional control using FEV1/FVC ratio.
Measured: Evaluation at 12 months.
Adherence rate
Adherence rate using the Brief Medication Questionnaire [scale from 0 (best) to 11 (worst) points]
Measured: 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.
Measured: Evaluation at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Jun 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms single blinded randomised controlled trial with a 1 year follow up
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro-Aradas Family Health Unit
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Maricoto, Aveiro-Aradas Family Health Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449316
- Sponsor's protocol ID
- Protocol V3
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30696670
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03449316
- Acronym / sponsor ID
- Protocol V3
- Keywords
- Nebulizers and Vaporizers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Aveiro-Aradas Family Health UnitUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms single blinded randomised controlled trial with a 1 year follow up
| Arm | Type | Receives |
|---|---|---|
| Inhaler technique education | Experimental | Behavioral: Inhaler technique educationThis 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 65 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaler technique educationTeaching of inhalers use with placebo devices in real training | Behavioural | Inhaler technique education |
Primary outcome
Adverse events
Time frame: Evaluation at 12 months.
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.
14 secondary outcomes
Clinical assessment
Time frame: Evaluation at 12 months
Clinical assessment
Time frame: Evaluation at 12 months
Clinical assessment
Time frame: Evaluation at 12 months
Clinical assessment
Time frame: Evaluation at 12 months
Quality of Life
Time frame: Evaluation at 12 months.
Quality of Life
Time frame: Evaluation at 12 months.
Quality of Life
Time frame: Evaluation at 12 months.
Functional control
Time frame: Evaluation at 12 months.
Functional control
Time frame: Evaluation at 12 months.
Functional control
Time frame: Evaluation at 12 months.
Functional control
Time frame: Evaluation at 12 months.
Functional control
Time frame: Evaluation at 12 months.
Adherence rate
Time frame: Evaluation at 12 months.
Inhaler technique performance
Time frame: Evaluation at 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Derived from this study: PubMed 30696670Maricoto 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhaler technique education in people with Asthma and COPD, run by Aveiro-Aradas Family Health Unit.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Evaluation at 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.