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Clinical Trials/EUCTR2019-003082-17-DE
EUCTR2019-003082-17-DE
Active, not recruiting
Phase 1

EFFECT OF ELECTRONIC MONITORING AND FEEDBACK ON ADHERENCE TO EASYHALER CONTROLLER MEDICATION IN PATIENTS WITH ASTHMA - eMOFEE

Orion Corporation Orion Pharma0 sites166 target enrollmentNovember 29, 2019
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ConditionsAsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsBudesonid Orion Easyhaler 0,2 mg/DosisBudesonid Orion Easyhaler 0,4 mg/DosisBufori Easyhaler 160 Mikrogramm/4,5 MikrogrammBufori Easyhaler 320 Mikrogramm/9 MikrogrammFlusarion Easyhaler 50 Mikrogramm/250 MikrogrammFlusarion Ea

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Asthma
Sponsor
Orion Corporation Orion Pharma
Enrollment
166
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 29, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Written informed consent obtained.
  • •2\. Male and female subjects with documented diagnosis of asthma.
  • •3\. Age 18 to 65 years, inclusive.
  • •4\. ACT score 19 or less at screening (visit 1\).
  • •5\. Subject must have been using budesonide, budesonide/formoterol combination or salmeterol/fluticasone propionate combination as his/her controller medication at constant dose for at least 3 months prior to screening and be able to switch to use the same active substance(s) via Easyhaler. Subjects already using budesonide, budesonide/formoterol combination or salmeterol/fluticasone propionate combination Easyhaler are also eligible.
  • •6\. Subject must be able to switch his/her rescue medication to salbutamol Easyhaler for the duration of the study.
  • •7\. A course of oral corticosteroid for asthma exacerbation in the previous year, or a history of a hospitalisation or emergency department visit with an asthma exacerbation in the last year.
  • •8\. Subject must be able to speak and read German.
  • •9\. Subject must have their own Android (version 5\.0 or later) or iPhone operating system (IOS, version 11\.0 or later) smart phone and a data package suitable for the installation and running of the mobile application and sending and receiving data.
  • •10\. Subject must be willing and able to accept Propeller Health’s User Agreement and Privacy and Cookies Policy, download the mobile application on their smartphone, and keep Wi Fi/mobile data, Bluetooth, and the mobile application on for the duration of the study.

Exclusion Criteria

  • •1\. Change of asthma controller medication during the last 3 months before visit 1 or during the run\-in period.
  • •2\. Asthma exacerbation requiring a course of systemic (e.g. oral) corticosteroid, hospitalisation or emergency department visit within 1 month before visit 1 or during the run\-in period.3\. Concomitant major respiratory disease (e.g. COPD) which, in the opinion of the investigator, may complicate the measurement of asthma control.
  • •4\. Smokers or ex\-smokers with \> 20 pack\-year history of smoking.
  • •5\. An acute upper or lower respiratory tract infection within 14 days before visit 1 or visit 2\.
  • •6\. Subjects who are receiving or have received an investigational drug within 30 days before visit 1, or within 5 half\-lives (whichever is longer), or who are participating or have participated in a study using connected inhalers.
  • •7\. Any significant medical disease or condition or other factor that, in the investigator’s opinion, might interfere with study assessments or study participation.
  • •8\. A family member living in the same household already enrolled in the study.
  • •9\. Pregnant (positive pregnancy test at screening) or lactating female subjects.
  • •10\. Women of childbearing potential (WOCBP) not using an acceptable contraception.
  • •11\. Subject is in a dependent relationship with the investigator/study site/sponsor of the clinical study.

Outcomes

Primary Outcomes

Not specified

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