Inhaler Research V1

• Research type

  Research Study

• Full title

  Inhaler Research - A usability study comparing inhalers used for asthma and COPD

• IRAS ID

  216556

• Contact name

  Alper Hulusi

• Contact email

  George.Ashford@creativemedicalresearch.com

• Duration of Study in the UK

  0 years, 3 months, 19 days

• Research summary

  The primary objective for this research is to understand how the usability of the PulmoJet inhaler compares to competitor devices to enable marketing claims to be validated and supported by robust, patient and nurse data. This will enable the sponsor company to identify benefits from a patient care perspective of its device versus competitor devices.

  The inhalers to be included in the study are:

  PulmoJet
  Turbuhaler
  Diskus

  The methodology for this study is face to face interviews with trained use of empty inhalers.

  The study will consist of interviews with Respiratory nurses and Asthma/COPD patients. All interviews will take place at a central location and be moderated by an experienced moderator. In order to identify the strengths and weaknesses of each inhaler and to determine their preferences, a combination of data capture techniques will be used. These will include observational recording, quantitative questions with some qualitative probes (open ended questions asked to understand responses to quantitative questions). Participants will also be asked to handle the inhalers under guidance from the study moderator and to take a dose. None of the inhalers will contain any medication and all inhalers will be collected at the end of the research for return to the sponsor company. All research will follow the Market Research Society (MRS) guidelines with respect to the treatment of participants and their data in a professional and ethical manner. All data resulting from the research will be managed in accordance with the Data Protection Act.

  Potential participants will be identified from a pre-existing database of research participants (members of the public and healthcare professionals who have consented to being contacted for the sole purpose of taking part in research). In addition participants will also be recruited through healthcare professional referrals and targeted social media advertising.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  16/EE/0507

• Date of REC Opinion

  7 Dec 2016

• REC opinion

  Unfavourable Opinion