Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Study acronym: BRISOTE
StatusCompleted
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Trial sites reduced: 160 → 86 locations
    • Final enrollment: 130 participants (planned 400)
    • Primary completion date changed from estimate of Nov 3, 2028 to Sep 21, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 5 of 7 entries
  2. Primary and study completion pushed from Nov 3, 2027 to Nov 3, 2028
    • Trial sites expanded: 157 → 160 locations
    v10
  3. Study sites: 141 to 157
    • Primary and study completion dates: Nov 2, 2027 to Nov 3, 2027
    v9
  4. Study sites: 134 to 141v8
  5. Study sites: 133 to 134v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 131 to 133v6
  2. Study sites: 128 to 131v5
  3. Site details revised at 17 of 128 sitesv4
  4. Study sites: 126 to 128
    • Primary and study completion dates: Nov 3, 2027 to Nov 2, 2027
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 23 to 126
    • Primary and study completion dates: Oct 29, 2027 to Nov 3, 2027
    • Start date changed from estimate of Mar 31, 2025 to Mar 28, 2025
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
729 trials monitored
See 62 trials at risk
Asthma
958 trials monitored
See 36 trials at risk
This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.
Trial Details
NCT Number NCT06750289
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 Eosinophilic Asthma
Related terms Pulmonary Eosinophilia
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov