Improved inhalation of drugs for patients with asthma and chronic obstructive lung disease
|Coordinator||Karolinska Universitetssjukhuset - Tema Barn och Kvinnosjukvård|
|Funding from Vinnova||SEK 940 750|
|Project duration||August 2018 - April 2019|
Purpose and goal
We accomplished the following goals; 1) The software was further developed based on information from clinical validation. We determined specifications and requirements for the hardware. 2) Performed regulatory and CE-marking strategy, and classification of the product, and structure for technical file. 3) Presentation of previous study and design of next study in collaboration with partners. 4) Business plan and analysis of bringing the product to market
Expected results and effects
We expect that the results of this project and the novel inhalation app will provide improved health in patients with respiratory diseases. The solution also proved valuable support for health care providers when evaluating inhalation technique. The planned prospective study will assess the effect of educating patients in inhalation technique with automated objective measurement. The regulatory strategy demonstrates the way of CE-marking the product.
Planned approach and implementation
The project has accomplished the set goals in each of four work packages. The Karolinska University Hospital was principal organizer of the project to ensure the clinical benefit. Collaborators within the network of Medituner AB, provided important information about the business case, hard ware supplier MIR gave their support to development adjustable resistances that can be used together with the spirometer, and regulatory expert demonstrated the process for CE-mark.