The effects of RPL554 on top of standard COPD reliever medications

  • Research type

    Research Study

  • Full title

    A phase II, randomised, double blind, placebo controlled, six way crossover study to assess the bronchodilator effect of RPL554 administered on top of salbutamol and ipratropium in patients with COPD

  • IRAS ID

    184901

  • Contact name

    Katharine Abbott-Banner

  • Contact email

    Kathy.Abbott-Banner@veronapharma.com

  • Sponsor organisation

    Verona Pharma plc

  • Eudract number

    2015-002536-41

  • Duration of Study in the UK

    0 years, 4 months, 15 days

  • Research summary

    The purpose of this study is to assess the bronchodilator effect (opening of the airways) of RPL554 when used in combination with standard bronchodilator treatment in moderate chronic obstructive pulmonary disease (COPD) patients.

    This study is a Phase IIa, randomised, double blind, placebo controlled, six way crossover study to investigate combination treatment with nebulised RPL554 and salbutamol or ipratropium compared to salbutamol or ipratropium alone.

    The aim is for each of the 30 patients enrolled to complete six separate 1 day treatment visits. At each of these visits the patient will receive a single dose from a blinded inhaler containing salbutamol or matching placebo (Dummy drug containing no active ingredient), followed by a single dose from a second blinded inhaler containing ipratropium or matching placebo. This will then be followed by a single blinded dose of the RPL554 or placebo.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    15/EM/0307

  • Date of REC Opinion

    29 Jul 2015

  • REC opinion

    Further Information Favourable Opinion