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

October 31, 2024 updated by: Orion Corporation, Orion Pharma
Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • MECS Research GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Subjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application
Other: Reminders and feedback to improve adherence
Subjects will receive reminders and feedback to improve their adherence.
Active Comparator: Usual care
Subjects do not receive reminders and feedback, but receive treatment as usual.
Other: No reminders and feedback to improve adherence
Subjects will not receive reminders and feedback to improve their adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Weekly during each of the last 6 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Study Director: Orion Corporation Clinical Study Director, Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2021

Primary Completion (Actual)

April 24, 2024

Study Completion (Actual)

April 24, 2024

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3103017
  • 2019-003082-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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