Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
VisionHealth GmbH
With
Thoraxklinik-Heidelberg gGmbH
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A subject is eligible to be included in the study only if all of the following criteria apply:
Age
1. At least 18 years of age at the time of signing the informed consent.
Sex
2. Male or female.
Type of Subject and Disease Characteristics
3. Sufficient knowledge of the German language as assessed by the Investigator.
4. Capability to use a smartphone comfortably in the opinion of the Investigator: the subject uses a smartphone on a regular basis, and makes use of smartphone applications (i.e., uses the smartphone for more than calling and sending text messages).
5. Established diagnosis of asthma.
6. Regular use (i.e., at least once daily) of at least 1 of the following devices: metered-dose inhalers (MDIs), Respimat, NEXThaler, Ellipta, Easyhaler, Breezhaler and Turbohaler.
7. Stable disease (i.e., no exacerbation and/or change in treatment regimen) within the last 4 weeks prior to screening.
Informed Consent
8. Provision of written informed consent prior to any study specific procedure.
You may not be if
Subjects are excluded from the study if any of the following criteria apply:
Medical Conditions
1. History or evidence of any clinically relevant and/or major disease that, in the opinion of the Investigator, would constitute a risk when taking part in the study or interfere with the interpretation of data.
2. Confirmed SARS-CoV-2 infection at screening.
Prior/Concomitant Therapy
3. Previous use of the Kata Inhalations-App.
Prior/Concurrent Clinical Study Experience
4. Use of any investigational drug or participation in any clinical study within 30 days prior to the expected date of first application of study intervention.
5. Previous randomization in this study.
Other Exclusions
6. Employee of VisionHealth, the study site, the Nuvisan Group, or other Contract Research Organization involved in the study.
7. Legal incapacity or limited legal capacity, or incarceration.
8. Inability to understand or communicate reliably with the Investigator or considered by the Investigator to be unable to or unlikely to co-operate with the protocol requirements, instructions, and study-related restrictions.
9. Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.
