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

80

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

U

Uppsala University Hospital

Collaborating Sponsor

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 device's 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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 to 12 weeks

Participants receive education and training on inhalation technique using an app-based medical device combined with a spirometer and airflow trainer to improve their inhalation skills.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 3 locations

1

Healthcare centre

Styrsö, Västra Götaland County, Sweden, 430 84 Styrsö

Actively Recruiting

2

Uppsala University Hospital, Lung and Allergy Department

Uppsala, Sweden, 751 85, Uppsala

Actively Recruiting

3

Healthcare Centre

Boxholm, Östergötland County, Sweden, 595 70

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Similar Trials

A Multicenter, Prospective Trial Evaluating the Safety and E...

Emphysema or COPD

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Feasibility and effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial.

Carol L Armour, Helen K Reddel, Kate S LeMay...

https://pubmed.ncbi.nlm.nih.gov/23270495

The economic burden of asthma and chronic obstructive pulmonary disease and the impact of poor inhalation technique with commonly prescribed dry powder inhalers in three European countries.

A Lewis, S Torvinen, P N R Dekhuijzen...

https://pubmed.ncbi.nlm.nih.gov/27406133

The ADMIT series--Issues in Inhalation Therapy. 7. Ways to improve pharmacological management of COPD: the importance of inhaler choice and inhalation technique.

Mariëlle E A C Broeders, Walter Vincken, Lorenzo Corbetta...

https://pubmed.ncbi.nlm.nih.gov/21808941

Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial.

Henrik Ljungberg, Anna Carleborg, Hilmar Gerber...

https://pubmed.ncbi.nlm.nih.gov/31481605