Effects of the Kata® Inhalations-App on Inhaler Handling Errors, Adherence, and Asthma Control in Patients with Asthma.

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 improve their inhalation maneuver so that the drug reaches the lungs efficiently. The Kata® App aims to reduce inhalation errors and ensures that inhaled drugs are used as approved and prescribed. Kata has different trainers for different inhalation devices. This study investigates the possible positive effects of the Kata® Inhalation App.

The main goal of the study is to:

1. investigate the effect of using the Kata® App on adherence for inhaled drugs in adult asthma patients. It consists of two parts: the correct use of the inhalers; and compliance with the therapy, or how much the patient follows the therapy plan as prescribed.
2. investigate the effect of using the Kata® App on asthma symptoms and asthma control, as measured by the Asthma Control Test (ACT) questionnaire.

In addition, asthma-related quality of life, lung function, and ease of use of the app will be assessed during the study.

This multicenter study follows a randomized, controlled, parallel-group, adaptive two-stage design. The study includes two different groups: an intervention and a control group. At the beginning of the study, each patient is randomly assigned to one of these two groups. The total duration of the study is 13 weeks: 1 baseline week and 12 intervention weeks. During the baseline week, the intervention and control group both use the app with limited functionality. Kata records their inhalations but does not provide inhalation training or feedback. This is to first assess how well patients are able to use their inhaler(s) without receiving support. After the first week, the intervention group starts using the app with full functionality for 12 weeks, which means that the app provides them with inhalation training and personalized feedback. The control group continues to use the app with limited functionality for 12 weeks, that means that they continue to use the app to record their inhalations but do not receive any inhalation training or feedback. This study will compare the patients in the intervention and control group, to find out the effect of using the Kata® inhalation app on the number of errors patients make when using their inhaler, therapy compliance, and health-related outcomes (asthma control, quality of life, and lung function).


Eligibility Criteria:
Inclusion Criteria

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.

Exclusion Criteria

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.