Status:
COMPLETED
Effects of the Kata® Inhalations-App on Inhaler Handling Errors, Adherence, and Asthma Control in Patients With Asthma.
Lead Sponsor:
VisionHealth GmbH
Collaborating Sponsors:
Thoraxklinik-Heidelberg gGmbH
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Kata® App is a digital therapy assistant for patients with asthma who need to inhale their therapy. Kata features inhalation trainers that shows patients in a simple and understandable way how to ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- A subject is eligible to be included in the study only if all of the following criteria apply:
- Age
- At least 18 years of age at the time of signing the informed consent.
- Sex
- Male or female.
- Type of Subject and Disease Characteristics
- Sufficient knowledge of the German language as assessed by the Investigator.
- 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).
- Established diagnosis of asthma.
- 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.
- Stable disease (i.e., no exacerbation and/or change in treatment regimen) within the last 4 weeks prior to screening.
- Informed Consent
- Provision of written informed consent prior to any study specific procedure.
- Exclusion Criteria
- Subjects are excluded from the study if any of the following criteria apply:
- Medical Conditions
- 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.
- Confirmed SARS-CoV-2 infection at screening.
- Prior/Concomitant Therapy
- Previous use of the Kata Inhalations-App.
- Prior/Concurrent Clinical Study Experience
- 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.
- Previous randomization in this study.
- Other Exclusions
- Employee of VisionHealth, the study site, the Nuvisan Group, or other Contract Research Organization involved in the study.
- Legal incapacity or limited legal capacity, or incarceration.
- 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.
- Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.
Exclusion
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06178341
Start Date
December 20 2023
End Date
January 14 2025
Last Update
June 17 2025
Active Locations (13)
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1
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany, 69126
2
MVZ Dachau
Dachau, Bavaria, Germany, 85221
3
Lunge im Zentrum
Erlangen, Bavaria, Germany, 91054
4
Herzzentrum des Universitätsklinikums Bonn
Bonn, Germany