At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,767 enrolled
Drug / intervention
Brensocatib 10 mg +2 moredrug
Likely dose
Brensocatib 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Brensocatib 10 mg, Brensocatib 25 mg, and 1 other intervention for Non-Cystic Fibrosis Bronchiectasis. Completed, enrolled 1,767 participants across 373 sites in 36 countries.
Detailed Summary
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Cystic Fibrosis Bronchiectasis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Serbia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartDec 2020
Primary CompletionOct 2024
TodayJul 2026
First PostedOct 20, 2020
Enrollment StartDec 1, 2020
Primary CompletionOct 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.7 years ago
Interventions
Brensocatib 10 mgdrug
Oral tablet.
Brensocatib 25 mgdrug
Oral tablet.
Placebodrug
Brensocatib-matching oral tablet.