Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
eMOFEE
2 other identifiers
interventional
158
1 country
1
Brief Summary
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started Jun 2021
Typical duration for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedStudy Start
First participant enrolled
June 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2024
CompletedNovember 4, 2024
October 1, 2024
2.8 years
April 27, 2021
October 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mean weekly adherence to controller medication
Adherence (percentage of doses taken of the doses prescribed) to controller medication during last six weeks of study
Weekly during each of the last 6 weeks of treatment
Study Arms (2)
Intervention
EXPERIMENTALSubjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application
Usual care
ACTIVE COMPARATORSubjects do not receive reminders and feedback, but receive treatment as usual.
Interventions
Subjects will receive reminders and feedback to improve their adherence.
Subjects will not receive reminders and feedback to improve their adherence.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MECS Research GmbH
Berlin, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Orion Corporation Clinical Study Director
Orion Corporation, Orion Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
May 3, 2021
Study Start
June 23, 2021
Primary Completion
April 24, 2024
Study Completion
April 24, 2024
Last Updated
November 4, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share