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

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

Completed

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MECS Research GmbH

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reminders and feedback to improve adherence

Other

Subjects will receive reminders and feedback to improve their adherence.

No reminders and feedback to improve adherence

Other

Subjects will not receive reminders and feedback to improve their adherence.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Acronym: eMOFEE

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: May 3, 2021
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed