What is this study trying to find out about asthma and COPD?

This study is evaluating whether an app-based education and training tool can improve inhaler technique for people with asthma or COPD. Researchers want to see if using the app helps patients use their inhalers more successfully over a 6 to 12-week period. The study is sponsored by Karolinska Institutet and aims to support better inhaler use through digital technology.

Who may be eligible for this asthma and COPD clinical trial?

Participants must be 16 years or older with a doctor's diagnosis of asthma or COPD and currently using daily inhaler therapy with DPI or MDI devices. They must have access to a smartphone and be able to use electronic identification like BankID. Ability to inhale and handle the inhaler independently is required. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma and COPD clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect support to use the app and devices during the study without paying for these services.

Actively Recruiting

Phase Not Applicable

Age: 16Years +

All Genders

ID07145632

App-Based Medical Device for Education and Training of Inhalation Technique in Asthma and COPD

Led by Karolinska Institutet · Updated on 2025-08-28

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether an app-based education and training tool can improve how well people with asthma or COPD use their inhalers. The study compares this new app-based method with standard inhaler education over 6 to 12 weeks. The goal is to see if the app helps patients perform inhalation techniques more successfully, while also evaluating the ease of use and safety of the app-based device. Participants will be randomly assigned to one of two groups one group receives standard care with traditional inhaler education, and the other group uses an app-based medical device incorporated into the AsthmaTuner system. This device includes a Bluetooth-connected spirometer and an Airflow Trainer that simulates inhaler resistance, providing automated feedback on inhalation flow, time, and technique. The intervention group will use the app daily to train and improve their inhalation technique, while the control group receives standard non-app education. Patients will be assessed at the start and at a 6 to 12-week follow-up visit. Evaluations include subjective assessments by respiratory nurses and objective measurements such as peak inspiratory flow, time to peak flow, inhalation time, and breath hold duration. Questionnaires and interviews will gather data on the devices usability and safety. Researchers will analyze the rate of successful inhalation techniques and the feasibility of the app to support patients in managing their inhaler use.

CONDITIONS

Brief Title

APP-based Medical Device for Education and Training of Inhalation Technique

Who Can Participate

Age: 16Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age greater than 16 years
Willing to voluntarily participate and provide electronic informed consent using BankID or similar
Daily inhalation therapy through dry powder inhaler (DPI) and/or metered dose inhaler (MDI)
Doctor's diagnosed asthma or COPD

You will not qualify if you...

Age less than 16 years
No access to use BankID or similar electronic personal identification
No smartphone of type Android or iPhone
Plan to stop using DPI and/or MDI treatment within 6-12 weeks from inclusion
Medical condition affecting ability to independently inhale or use DPI or MDI devices

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