Breathing Face Mask and Mouthpiece User Research Study V 1.0
Research type
Research Study
Full title
Breathing Face Mask and Mouthpiece User Research Study
IRAS ID
207141
Contact name
B. Louisa Harvey
Contact email
Sponsor organisation
Vectura GmbH
Duration of Study in the UK
0 years, 0 months, 4 days
Research summary
This user research is part of the user engineering (usability) to identify and select the best-device design options for a commercial smart nebuliser device (AKITA JET) for the treatment of asthma in children. The research is conducted by interviewing children and parents and testing usability with inhalation devices. Vectura does not capture safety or efficacy data within this user research.\n\nCurrent inhalation treatments of asthma in children are often associated with long therapy times and highly-variable dosing of drug compounds. When inhalation treatment takes too long, children reject the therapy and parents struggle to conduct an effective therapy. By developing a new inhalation system for children Vectura plc intends to improve treatment of asthma in children by:\n\n-\tReducing the dosing time in children\n-\tProviding precise dosing and avoiding unnecessarily high drug applications\n-\tProviding an effective inhalation system adequate for children from 1 to 8 years\n\nAs part of this development, usability of the inhalation system should be optimised for the patient population. Therefore, Vectura plc intends to conduct a user research study to identify a face mask concept that helps to meet this aim. Furthermore, it is planned to identify if children from aged from 1 to 8 years are able to inhale via a mouth piece in combination with Vectura’s preferred technology. Patient training is another important parameter which is often underestimated, and therefore training will be investigated in this research. Within this user research it will be investigated how training can influence and improve pulmonary drug delivery in children. \n\nThis user research is designed to reduce risk to the participants whilst discovering the most appropriate design to take forward.
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0551
Date of REC Opinion
18 Jul 2016
REC opinion
Favourable Opinion