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

• Sponsor: Orion Corporation, Orion Pharma (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04869384
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.3
• Patients Per Site Per Month: 10.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Other: Reminders and feedback to improve adherence; Other: No reminders and feedback to improve adherence	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
• Actual Study Start Date: Jun 23, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Mean weekly adherence to controller medication [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MECS Research GmbH	Berlin		Germany

Sponsors and Collaborators

• Orion Corporation, Orion Pharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orion Corporation, Orion Pharma
• ClinicalTrials.gov Identifier: NCT04869384
• Other Study ID Numbers: 3103017; 2019-003082-17
• First Posted: May 3, 2021
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Jul 30, 2021