AsthmaPhase 4eMOFEENCT04869384
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
A Phase 4 study testing Reminders and feedback to improve adherence and No reminders and feedback to improve adherence in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Germany.
Trial summary
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Reminders and feedback to improve adherence and No reminders and feedback to improve adherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jun 2021to 24 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion Criteria:
- written informed consent
- male and female subjects with documented diagnosis of asthma
- age 18 to 65 years
- ACT score 19 or less at screening
- treatment wih oral corticosteroids or hospital or emergency department admission due to asthma exacerbation within the past year
- subject's able to use Easyhaler inhalers and comply with study requirements
Main exclusion Criteria:
- recent (within 1 month) asthma exacerbation
- concomitant major respiratory disease which may complicate the measurement of asthma control
- >20 pack-year history of smoking
- recent upper or lower respiratory tract infection
- pregnant or lactating female subjects
Trial locations and contacts
1 site in 1 country.
About this study
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma
- Conditions
- Asthma
- Being tested
- Reminders and feedback to improve adherence, No reminders and feedback to improve adherence
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminders and feedback to improve adherenceOther
Subjects will receive reminders and feedback to improve their adherence.
No reminders and feedback to improve adherenceOther
Subjects will not receive reminders and feedback to improve their adherence.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application Receives: Other: Reminders and feedback to improve adherence |
| Usual care | Active comparator | Subjects do not receive reminders and feedback, but receive treatment as usual. Receives: Other: No reminders and feedback to improve adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weekly adherence to controller medication
Adherence (percentage of doses taken of the doses prescribed) to controller medication during last six weeks of study
Measured: Weekly during each of the last 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start23 Jun 2021
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orion Corporation Clinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869384
- Sponsor's protocol ID
- 3103017
- Other IDs
- 2019-003082-17, 2019
- Acronym
- eMOFEE
- Status last verified
- Oct 2024
- First submitted
- 27 Apr 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
- ClinicalTrials.gov ID
- NCT04869384
- Acronym / sponsor ID
- eMOFEE / 3103017
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 3 May 2021 (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.
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Reminders and feedback to improve adherenceSubjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application |
| Usual care | Active comparator | Other: No reminders and feedback to improve adherenceSubjects do not receive reminders and feedback, but receive treatment as usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Reminders and feedback to improve adherenceSubjects will receive reminders and feedback to improve their adherence. | Other | Intervention |
| No reminders and feedback to improve adherenceSubjects will not receive reminders and feedback to improve their adherence. | Other | Usual care |
Primary outcome
Mean weekly adherence to controller medication
Time frame: Weekly during each of the last 6 weeks of treatment
Adherence (percentage of doses taken of the doses prescribed) to controller medication during last six weeks of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Orion Corporation Clinical Study Director study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reminders and feedback to improve adherence and No reminders and feedback to improve adherence in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 4 Nov 2024. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean weekly adherence to controller medication (time frame: Weekly during each of the last 6 weeks of treatment). 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 4 Nov 2024.