Breath Actuated Inhaler Human Factors Placebo Study

• Research type

  Research Study

• Full title

  Usability Investigative (formative) Study-Comparing use of Empty Devices verses Devices with Placebo

• IRAS ID

  182498

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@parexel.com

• Sponsor organisation

  AstraZeneca

• Duration of Study in the UK

  0 years, 0 months, 30 days

• Research summary

  The proposed Usability / Human Factor Engineering (HFE) study is to investigate how users interact with a newly developed Breath Actuated pressurised Metered Dose Inhaler device (BA MDI) for use with inhaled drugs for the treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
  The study is part of a program of work to ensure that the design of this new device and it’s Instructions For Use (IFU) will not lead to safety critical patient misuse.
  The study will compare participant’s use of empty devices vs. devices fitted with placebo canisters that delivers an aerosol spray when used correctly.
  This study will recruit healthy males and females from the age 18 years and above and patients of the same age group with Asthma and COPD. The study will include naive and experienced inhaler users in separate arms.
  The data collected will be through non-intrusive live observation and, if appropriate, through analysis of session video footage after completion of the study

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0243

• Date of REC Opinion

  29 Mar 2016

• REC opinion

  Favourable Opinion