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Study to Evaluate Efficacy and Safety of BLU-593 in Adults with RCC

  • Research type

    Research Study

  • Full title

    A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel Arm, Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses of BLU-5937 in Adult Participants With Refractory Chronic Cough

  • IRAS ID

    289963

  • Contact name

    Jaclyn Smith

  • Contact email

    Jacky.Smith@manchester.ac.uk

  • Sponsor organisation

    Bellus Health Inc

  • Eudract number

    2020-004136-17

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    A chronic cough is a cough that lasts for 8 weeks or more. It is called refractory chronic cough (RCC) if it continues after optimal treatment for the underlying disease causing the cough. It is called unexplained chronic cough where no underlying disease can be identified. Although RCC/UCC is common, there are no approved medicines for the treatment of RCC/UCC.

    This clinical research study will investigate the effectiveness and safety of a new treatment, BLU-5937. This compound blocks the receptors in the airways that are believed to play a role in the hypersensitization of the cough reflex, leading to refractory chronic coughs.

    The main aims of this study will be to test the safety and efficacy and determine the optimal dose of BLU-5937 in participants with refractory chronic cough. Participants will be placed randomly into one of four treatment groups in a 1:1:1:1 ratio, to take orally, twice a day, either 12.5mg, 50mg, 200mg or placebo. Placebo is a “dummy” tablet that looks like BLU-5937 but with no active ingredients.

    A global total of 240 participants will be included in the study, there will be approximately 22 UK sites.

    Participants will take part in the study for a maximum of 12 weeks. This will be split into a screening period, treatment phase and follow-up period. Participants will attend 8 study visits in total.

    In order to determine the effectiveness of BLU-5937, participants will be asked to wear a cough monitor for a period of 24 hours, on five occasions during their involvement in the study. Other procedures will include the completion of questionnaires, and safety assessments (physical examination, blood and urine tests, and electrocardiogram [ECG] to measure the electrical activity of your heart).

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference

    21/SC/0010

  • Date of REC Opinion

    25 Feb 2021

  • REC opinion

    Further Information Favourable Opinion