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
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