Phase 2 Study of BLU-5937 in Subjects with Chronic Cough (RELIEF)

  • Research type

    Research Study

  • Full title

    A Randomized, Double-blind, Placebo-Controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects with Unexplained or Refractory Chronic Cough (RELIEF)

  • IRAS ID

    260431

  • Contact name

    Jacky Smith

  • Contact email

    jacky.smith@manchester.ac.uk

  • Sponsor organisation

    Bellus Health Inc.

  • Eudract number

    2019-000375-16

  • Duration of Study in the UK

    1 years, 2 months, 1 days

  • Research summary

    The treatment of refractory chronic cough is currently an unmet medical need. Over-sensitisation of nerves in the airway seems to be related to the activation of such coughs. P2X3 receptors are located on these airway nerves. These nerves can become sensitised by the action of adenosine triphosphate (ATP) when ATP is released by damaged, stressed or inflamed tissues. The new compound BLU-5937 has been shown to block P2X3 receptors sensitised by ATP, which explains why BLU-5937 may be useful in the treatment of chronic cough.
    In this study subjects will first be allocated randomly to treatment with either BLU-5937 or placebo (inactive but looks the same). After this treatment period they will then swap to the other treatment for the same period of time. Each of the 2 periods of treatment will last for 16 days, with a 14 day wash-out period in between. When treated with BLU-5937 each of the following doses will be taken orally twice a day, for 4 days: 25mg, then 50mg, then 100mg then finally 200mg. When treated with placebo the placebo tablets will match BLU-5937 so the subject and study staff will not know whether active or placebo tablets are being taken during each treatment period. Subjects will be randomised equally to start with either BLU-5937 or Placebo, and then swap treatments for the 2nd period.
    Subjects will be recruited from sites with specialist cough clinics at about 8 UK & 2 US sites. A total of 51 subjects will be allocated to the treatments.
    The subjects will be closely monitored for safety and effectiveness of their treatment. Effectiveness will be based upon changes in cough frequency measured objectively by portable recording devices worn by the subjects. Subjects will also be asked to rate any change in their cough after each dose level of treatment, using questionnaires.

  • REC name

    North West - Haydock Research Ethics Committee

  • REC reference

    19/NW/0181

  • Date of REC Opinion

    14 Jun 2019

  • REC opinion

    Further Information Favourable Opinion