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

Orion Pharma

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Other: Reminders and feedback to improve adherence; Other: No reminders and feedback to improve adherence

Study type: Interventional

Funder types: Industry

Identifiers

NCT04869384

2019-003082-17 (EudraCT Number)

3103017

Details and patient eligibility

About

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

Enrollment: 158 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

158 participants in 2 patient groups

Intervention

Experimental group

Description:

Subjects will receive reminders and feedback to improve their adherence via a sensor attached to Easyhaler inhaler and mobile application

Treatment:

Other: Reminders and feedback to improve adherence

Usual care

Active Comparator group

Description:

Subjects do not receive reminders and feedback, but receive treatment as usual.

Treatment:

Other: No reminders and feedback to improve adherence