Asthma ChronicNCT02283008
Inhaler Technique Training
A study testing Assessment of inhaler technique pre and 6 weeks post training in people with Asthma Chronic and Obstructive Pulmonary Disease, run by Northampton General Hospital NHS Trust.
Trial summary
The evidence for poor inhaler technique is both well established and observed worldwide. What is unclear from the evidence is why individuals demonstrate poor technique, despite the majority admitting to having previously had instruction on inhaler technique. Read more about this study
- Who is it for?
- Ages 35 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma Chronic, Obstructive Pulmonary Disease
- What is being tested?
- Assessment of inhaler technique pre and 6 weeks post training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2015
- Phase
- Interventional
- 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 35 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria will be anybody whose regular treatment requires inhaled medication. They will be included regardless of age, disease, inhaler device used or cognition.
Who cannot join
- The only exclusion criteria will be if a willing participant is not on an inhaler of any type.
About this study
Official title: Evaluating the Efficacy of 2 Different Educational Strategies for Improving and Maintaining Inhaler Technique
The evidence for poor inhaler technique is both well established and observed worldwide. What is unclear from the evidence is why individuals demonstrate poor technique, despite the majority admitting to having previously had instruction on inhaler technique. The primary research question is 'Will there be a difference between post education inhaler technique scores when comparing structured education against informal education?'
To try and establish why individuals use inhalers incorrectly a semi structured interview is proposed
- Conditions
- Asthma Chronic, Obstructive Pulmonary Disease
- Being tested
- Assessment of inhaler technique pre and 6 weeks post training
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of inhaler technique pre and 6 weeks post trainingBehavioural
Assessment of inhaler technique on day one. Education package and training on inhaler use at week 2. Final assessment to establish maintenance of inhaler competence at week 8
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | This arm will receive standard care which involves informal education on how to use metered dose inhalers |
| Structured education | Active comparator | This arm will receive structured education on the use of inhalers. At 6 weeks post education inhaler technique will be re-assessed. Participants who fail to achieve a set level of competence may be chosen for semi structured interview. Receives: Behavioral: Assessment of inhaler technique pre and 6 weeks post training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaler technique scores will be compared at 6 weeks post inhaler technique education. The proportion achieving proficiency will be compared between those recieving usual care and those recieving structured care.
Measured: 6 weeks per cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChronicStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northampton General Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Hickey, Northampton General Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283008
- Sponsor's protocol ID
- IRAS Project ID: 153018
- Status last verified
- Oct 2014
- First submitted
- 31 Oct 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of 2 Different Educational Strategies for Improving and Maintaining Inhaler Technique
- ClinicalTrials.gov ID
- NCT02283008
- Acronym / sponsor ID
- IRAS Project ID: 153018
- Conditions
- Asthma Chronic, Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northampton General Hospital NHS TrustUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 5 Nov 2014 (estimated)
- 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.
The evidence for poor inhaler technique is both well established and observed worldwide. What is unclear from the evidence is why individuals demonstrate poor technique, despite the majority admitting to having previously had instruction on inhaler technique. The primary research question is 'Will there be a difference between post education inhaler technique scores when comparing structured education against informal education?'
To try and establish why individuals use inhalers incorrectly a semi structured interview is proposed
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –This arm will receive standard care which involves informal education on how to use metered dose inhalers |
| Structured education | Active comparator | Behavioral: Assessment of inhaler technique pre and 6 weeks post trainingThis arm will receive structured education on the use of inhalers. At 6 weeks post education inhaler technique will be re-assessed. Participants who fail to achieve a set level of competence may be chosen for semi structured interview. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will be anybody whose regular treatment requires inhaled medication. They will be included regardless of age, disease, inhaler device used or cognition.
Key exclusion criteria (1 listed)
- The only exclusion criteria will be if a willing participant is not on an inhaler of any type.
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 |
|---|---|---|
| Assessment of inhaler technique pre and 6 weeks post trainingAssessment of inhaler technique on day one. Education package and training on inhaler use at week 2. Final assessment to establish maintenance of inhaler competence at week 8 | Behavioural | Structured education |
Primary outcome
Inhaler technique scores will be compared at 6 weeks post inhaler technique education. The proportion achieving proficiency will be compared between those recieving usual care and those recieving structured care.
Time frame: 6 weeks per cohort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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 study testing Assessment of inhaler technique pre and 6 weeks post training in people with Asthma Chronic and Obstructive Pulmonary Disease, run by Northampton General Hospital NHS Trust.
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 5 Nov 2014. 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.
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?
Inhaler technique scores will be compared at 6 weeks post inhaler technique education. The proportion achieving proficiency will be compared between those recieving usual care and those recieving structured care. (time frame: 6 weeks per cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2014; AzTrials last refreshed its copy on 28 Oct 2026.