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Phase IIA study of PC945 in Aspergillosis on Asthmatic subjects

  • Research type

    Research Study

  • Full title

    A double-blind, placebo-controlled study to assess the effects of inhaled PC945 in the treatment of culture-positive Aspergillus fumigatus infection in subjects with moderate to severe asthma

  • IRAS ID

    246673

  • Contact name

    Andrew Wardlaw

  • Contact email

    aw24@leicester.ac.uk

  • Sponsor organisation

    Pulmocide Ltd

  • Eudract number

    2018-000244-26

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    1 years, 4 months, 8 days

  • Research summary

    This is a double-blind, placebo controlled study to look at the effects of taking PC945 (study drug) or a placebo, by inhaler, to treat participants with a common airborne fungal infection, who also have moderate to severe asthma.

    Approximately 40 participants are to be recruited, from sites in the UK.

    Participants will be assigned on a 1:1 basis to receive either PC945 (study drug) or placebo (20 participants will be assigned to each group). Participants will continue to take their Standard of Care Asthma treatment during the study.

    Participants are expected to take part in the study for approximately 16 weeks. The study is split into three phases, consisting of

    1. a screening phase of up to 4 weeks;
    2. a 28 day treatment phase; and
    3. an 8 week follow up phase.

    Participants will be expected to make a total of 6 visits to their study centre. In addition, they will contacted by telephone by study staff on three occasions during the treatment phase.

  • REC name

    East Midlands - Derby Research Ethics Committee

  • REC reference

    18/EM/0166

  • Date of REC Opinion

    23 Jul 2018

  • REC opinion

    Further Information Favourable Opinion