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

NCT ID: NCT04869384

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2024-04-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Group Type EXPERIMENTAL

Reminders and feedback to improve adherence

Intervention Type OTHER

Subjects will receive reminders and feedback to improve their adherence.

Usual care

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

Group Type ACTIVE_COMPARATOR

No reminders and feedback to improve adherence

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reminders and feedback to improve adherence

Subjects will receive reminders and feedback to improve their adherence.

Intervention Type OTHER

No reminders and feedback to improve adherence

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Orion Corporation Clinical Study Director

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MECS Research GmbH

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3103017

Identifier Type: -

Identifier Source: org_study_id

2019-003082-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

STudy of Asthma Adherence Reminders
NCT02451709 COMPLETED NA