Back to resultsEffect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma (eMOFEE)
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Reminders and feedback to improve adherence
No reminders and feedback to improve adherence
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
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
Sites / Locations
- MECS Research GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Usual care
Arm Description
Subjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application
Subjects do not receive reminders and feedback, but receive treatment as usual.
Outcomes
Primary Outcome Measures
Mean weekly adherence to controller medication
Adherence (percentage of doses taken of the doses prescribed) to controller medication during last six weeks of study
Secondary Outcome Measures
Full Information
NCT ID
NCT04869384
First Posted
April 27, 2021
Last Updated
September 21, 2022
Sponsor
Orion Corporation, Orion Pharma
1. Study Identification
Unique Protocol Identification Number
NCT04869384
Brief Title
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
Acronym
eMOFEE
Official Title
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Subjects do not receive reminders and feedback, but receive treatment as usual.
Intervention Type
Other
Intervention Name(s)
Reminders and feedback to improve adherence
Intervention Description
Subjects will receive reminders and feedback to improve their adherence.
Intervention Type
Other
Intervention Name(s)
No reminders and feedback to improve adherence
Intervention Description
Subjects will not receive reminders and feedback to improve their adherence.
Primary Outcome Measure Information:
Title
Mean weekly adherence to controller medication
Description
Adherence (percentage of doses taken of the doses prescribed) to controller medication during last six weeks of study
Time Frame
Weekly during each of the last 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orion Corporation Clinical Study Director
Phone
(0115) 9487 100
Email
clinicaltrials@orionpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orion Corporation Clinical Study Director
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
Facility Information:
Facility Name
MECS Research GmbH
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schultz
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
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