Salmeterol and fluticasone Genetic DPI inhaler usability study

  • Research type

    Research Study

  • Full title

    Salmeterol and fluticasone Genetic DPI inhaler usability study

  • IRAS ID

    201643

  • Contact name

    Richard Featherstone

  • Contact email

    richard@medical-device-usability.com

  • Sponsor organisation

    Genetic SpA

  • Clinicaltrials.gov Identifier

    NA, None

  • Duration of Study in the UK

    0 years, 0 months, 8 days

  • Research summary

    This is a usability study of the instructions for two dry powder inhalers. The purpose is to evaluate how well patients adhere to the instructions when using the inhalers.
    60 participants will be enrolled in England: 15 children aged 4-12 years with asthma, 15 adolescents aged 13-17 years with asthma, 15 adults with asthma and 15 adults with COPD.
    Each participant will be given two empty inhalers (Seretide Accuhaler and a new inhaler not available in the UK), and will be asked to follow the instructions to simulate using it. An observer will note how many errors they make in their inhaler technique. The results will not be shared with the participant.
    Each participant will also be asked to inhale through an In-Check device to measure their inspiratory flow rate. The results will not be shared with the participant.

  • REC name

    South West - Central Bristol Research Ethics Committee

  • REC reference

    16/SW/0064

  • Date of REC Opinion

    16 Mar 2016

  • REC opinion

    Further Information Favourable Opinion