AsthmaNCT02977078
Improving Asthma Treatment Using Inhaler Technology
A study testing Active feedback on monitored inhaler use, Inhaler casing and Mobile application in people with Asthma, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Active feedback on monitored inhaler use, Inhaler casing and Mobile application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Apr 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months [i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months] patient reported.
- Doctor's diagnosis of asthma for at least 12 months
- On BTS step 2-5 treatment via MDI [monitoring devices to be utilised in the study are compatible with MDI inhalers]
- Use of own internet-enabled and compatible mobile phone
Who cannot join
- Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack Year History of smoking
- Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis
- Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')
Trial locations and contacts
1 site in 1 country.
Dominick Shaw contact
Maria Koufali contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
Nottingham, Nottinghamshire, NG7 2UH
Ireti Adejumo
About this study
This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse.
We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.
Read the detailed description
The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators.
The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting.
We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management.
Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.
- Conditions
- Asthma
- Being tested
- Active feedback on monitored inhaler use, Inhaler casing, Mobile application
- Keywords
- Inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active feedback on monitored inhaler useBehavioural
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
Inhaler casingDevice
Monitors inhaler use
Mobile applicationDevice
Mobile application software linked to inhaler casing
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use. Receives: Device: Inhaler casing |
| Active | Experimental | Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use Receives: Behavioral: Active feedback on monitored inhaler use; Device: Inhaler casing; Device: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period
Co-primary endpoint
Measured: Upto 24 weeks (study duration)
Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period
Co-primary endpoint
Measured: Upto 24 weeks (study duration)
Secondary outcomes (1)
Patient acceptability via qualitative feedback with questionnaires
Measured: Upto 24 weeks (study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Dominick Shaw, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977078
- Sponsor's protocol ID
- 14RM008
- Other IDs
- 193750
- Status last verified
- Dec 2016
- First submitted
- 18 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD
Publications
Adejumo I, Patel M, McKeever TM, Shaw DE. Does inhaler technology improve adherence and asthma control? A pilot randomized controlled trial. Ann Allergy Asthma Immunol. 2022 Jun;128(6):727-729. doi: 10.1016/j.anai.2022.02.023. Epub 2022 Mar 4. No abstract available.
PubMed 35257874
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Treatment Using Inhaler Technology
- ClinicalTrials.gov ID
- NCT02977078
- Acronym / sponsor ID
- 14RM008
- Conditions
- Asthma
- Keywords
- Inhaler
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 30 Nov 2016 (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.
This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse.
We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.
Detailed description
The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators.
The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting.
We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management.
Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: Inhaler casingInhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use. |
| Active | Experimental | Behavioral: Active feedback on monitored inhaler use, Device: Inhaler casing, Device: Mobile applicationInhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months [i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months] patient reported.
- Doctor's diagnosis of asthma for at least 12 months
- On BTS step 2-5 treatment via MDI [monitoring devices to be utilised in the study are compatible with MDI inhalers]
- Use of own internet-enabled and compatible mobile phone
Key exclusion criteria (3 listed)
- Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack Year History of smoking
- Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis
- Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')
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 |
|---|---|---|
| Active feedback on monitored inhaler useFeedback given on inhaler use by research nurse/ doctor based on mobile application feedback | Behavioural | Active |
| Inhaler casingMonitors inhaler use | Device | Active, Control |
| Mobile applicationMobile application software linked to inhaler casing | Device | Active |
Primary outcome
Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period
Time frame: Upto 24 weeks (study duration)
Co-primary endpoint
Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period
Time frame: Upto 24 weeks (study duration)
Co-primary endpoint
1 secondary outcome
Patient acceptability via qualitative feedback with questionnaires
Time frame: Upto 24 weeks (study duration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Derived from this study: PubMed 35257874Adejumo I, Patel M, McKeever TM, Shaw DE. Does inhaler technology improve adherence and asthma control? A pilot randomized controlled trial. Ann Allergy Asthma Immunol. 2022 Jun;128(6):727-729. doi: 10.1016/j.anai.2022.02.023. Epub 2022 Mar 4. No abstract available.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Dominick Shaw contact
Maria Koufali contact
Dominick Shaw principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active feedback on monitored inhaler use, Inhaler casing and Mobile application in people with Asthma, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 3 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Dominick Shaw (Dominic.Shaw@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period (time frame: Upto 24 weeks (study duration)). The study lists 2 primary outcomes in all. 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 NCT02977078, 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 7 Dec 2016.