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NCT04869384 Clinical Trial

Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma

Asthma Clinical Trial

— eMOFEE  

Official title:
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04869384
Other study ID # 3103017
Secondary ID 2019-003082-17
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 23, 2021
Est. completion date April 2023

Study information
Verified date September 2022
Source Orion Corporation, Orion Pharma
Contact Orion Corporation Clinical Study Director
Phone (0115) 9487 100
Email clinicaltrials@orionpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma

Recruitment information / eligibility
Status Recruiting
Enrollment 166
Est. completion date April 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Germany MECS Research GmbH Berlin

Sponsors (1)
Lead Sponsor Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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