Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
NCT ID: NCT04869384
Last Updated: 2024-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
158 participants
INTERVENTIONAL
2021-06-23
2024-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Subjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application
Reminders and feedback to improve adherence
Subjects will receive reminders and feedback to improve their adherence.
Usual care
Subjects do not receive reminders and feedback, but receive treatment as usual.
No reminders and feedback to improve adherence
Subjects will not receive reminders and feedback to improve their adherence.
Interventions
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Reminders and feedback to improve adherence
Subjects will receive reminders and feedback to improve their adherence.
No reminders and feedback to improve adherence
Subjects will not receive reminders and feedback to improve their adherence.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Orion Corporation Clinical Study Director
Role: STUDY_DIRECTOR
Orion Corporation, Orion Pharma
Locations
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MECS Research GmbH
Berlin, , Germany
Countries
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Other Identifiers
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3103017
Identifier Type: -
Identifier Source: org_study_id
2019-003082-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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