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ASPEN: Randomised study to assess the effect of Brensocatib in patients with NCFBE

  • Research type

    Research Study

  • Full title

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study

  • IRAS ID

    1003433

  • Contact name

    James Chalmers

  • Contact email

    jchalmers@dundee.ac.uk

  • Eudract number

    2020-003688-25

  • Research summary

    Non-cystic fibrosis bronchiectasis (hereafter referred to as NCFBE) is a chronic
    inflammatory disease defined by permanent dilatation of the bronchi. Participants suffer
    from daily cough and sputum production and experience frequent exacerbations (average
    frequency ranging from 1.5 to 6 per year). The prevalence of NCFBE has steadily
    increased over the past 10 years in both the United States and Europe. Despite an urgent
    need for treatment that can break the cycle of inflammation, infection, and irreversible
    progressive lung damage, there are no approved therapies specifically targeting this
    disease.
    This study will investigate the efficacy, safety, and tolerability of brensocatib in the
    clinical management of participants with NCFBE over 52 weeks. The goals are to
    confirm the findings from Study INS1007-201 and, if successful, to support marketing
    authorisations for brensocatib for the treatment of adult patients with NCFBE.
    All participants will complete the same study procedures. The study will last
    approximately 62 weeks from the Screening (Visit 1) to the End of Study (Visit 12). There
    will be 12 visits including the Screening Visit (1 visit), Treatment Visits (10 visits: 6 visits
    are in the clinic [Visits 2, 3, 5, 7, 9 and 11], and 4 visits by telephone from your home
    [Visits4, 6, 8 and 10]), and an End of Study Visit (1 visit). The End of Study Visit (Visit
    12).
    Approximately 1,620 participants between the ages of 18 and 85 years, with diagnosed
    NCFBE are expected to participate in this study. The study is being conducted at
    approximately 480 centers in North America, Europe, Japan, and the rest of the world.
    Approximately 68 of whom will participate in the UK.

  • REC name

    London - Surrey Borders Research Ethics Committee

  • REC reference

    20/LO/1194

  • Date of REC Opinion

    23 Dec 2020

  • REC opinion

    Further Information Favourable Opinion