Face Mask Human Factors Formative Study

• Research type

  Research Study

• Full title

  Face Mask Human Factors Formative Study

• IRAS ID

  223301

• Contact name

  B. Louisa Harvey

• Contact email

  louisa@harvey-medical.com

• Sponsor organisation

  Vectura GmbH

• Duration of Study in the UK

  0 years, 0 months, 4 days

• Research summary

  This formative human factors study has been planned in accordance with the FDA and EU usability engineering guidelines and standards. The study has been designed to reveal any use issues regarding the Face Mask design, which can only be identified through observing user interaction with the Face Mask. The use issues will be evaluated in terms of severity, and where necessary mitigated through design changes of the Face Mask, the instructions for use or training procedures.
  Vectura Group Plc are developing a new inhalation system for children with asthma to be used in combination with a face mask. Inhalation treatments for children are often associated with long therapy times and highly variable dosing of drug compounds.

  When inhalation treatments take too long, children reject the therapy and parents struggle to conduct an effective therapy. By developing a new inhalation system for children Vectura intends to improve the treatment of asthma in children by:

  • Reducing dose time
  • Providing precise dosing and avoiding high drug applications
  • Providing an effective inhalation system adequate for children

  A formative evaluation is required using the pilot production face mask in combination with an Akita nebuliser console which has been modified to deliver a reduced flow rate.
  This evaluation will be carried out prior to the start of a Phase II clinical study in the United States.

  The key objectives are as follows:

  • Observe usability and handling of the new face mask design by children/carers
  • Observe acceptability of the new face mask design
  • Observe that face mask is positioned correctly
  • Observe if child`s breathing can trigger the device
  • Observe that face mask inhalation and exhalation valves are unobstructed by holding the face mask
  • Observe whether the size of the face mask fits the target age group
  • Assess training and training decay

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  17/WM/0129

• Date of REC Opinion

  7 Apr 2017

• REC opinion

  Further Information Favourable Opinion