Asthma
Conditions
Interventions
Trade Name: Budesonid Orion Easyhaler 0,2 mg/Dosis
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Orion Corporation Orion Pharma
Eligibility
Sex/Gender
All
Inclusion 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. 11. Subject must be willing to share details of their e-mail address and phone number with Propeller Health to enable log-in and various alerts. For randomisation: 1. Subject is capable and willing to use the Easyhaler as demonstrated during the run-in period. 2. Subject is capable and willing to use the sensor and the mobile application as demonstrated during the run-in period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 166 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 12. Subjects who have been institutionalised as a result of an administrative or court order. 12.13. Subject has an active COVID-19 infection, i.e. currently has COVID-19 symptoms or has a current positive COVID-19 test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare adherence to controller medication between the intervention group using Connected Easyhaler and the control group (active usual care) during the last 6 weeks of the study.;Secondary Objective: The secondary objectives are to compare adherence to controller medication during the whole study, rescue medication usage, quality of life (QoL), asthma exacerbation and health care utilisation in patients with asthma between Connected Easyhaler system and active usual care. In addition, the secondary objectives include comparison of Asthma Control Test (ACT) score between the baseline and the end of study (change from baseline) within treatment groups.;Primary end point(s): Adherence to controller medication (the percentage of doses taken of the doses prescribed);Timepoint(s) of evaluation of this end point: During last 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adherence to controller medication (the percentage of doses taken of the doses prescribed) during the whole study - Mean daily reliever use and reliever free days will be calculated (e.g. percentage of rescue free days) during the whole study - Asthma Control Test (ACT) score at baseline, visit 2 (randomisation), visit 3 and visit 6 (at 6 months) - Quality of Life at baseline, visit 3 and visit 6 (at 6 months) - Severe and moderate asthma exacerbations during the whole study - Healthcare utilisation related to asthma at baseline, visit 3 and visit 6 (at 6 months) - Number of missed working or study days due to asthma symptoms during the whole study - Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at baseline, visit 3 and visit 6 (at 6 months) - Site satisfaction with the Connected Easyhaler system at the end of the study - Subject’s satisfaction with the sensor device, and the perception of the usability and the value of the digital health platform at the end of the study - Subject’s satisfaction (FSI-10 Questionnaire) and the preference with the inhaler at the end of the study;Timepoint(s) of evaluation of this end point: Timepoint(s) specified in section E.5.2 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information Desk
Orion Corporation Orion Pharma
Outcome results
None listed