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A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

NCT04159519 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-01-09

Study results available
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Summary

This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.

Conditions

  • Asthma
  • Severe Eosinophilic Asthma

Interventions

DRUG

Symbicort®

Participants will receive Budesonide 400 μg/formoterol fumarate 12 μg per inhalation or Budesonide 200 μg/formoterol fumarate 6 μg per inhalation.

DRUG

Fasenra®

Participants will receive Benralizumab 30 mg/mL, 1 mL fill volume via subcutaneous injection every 4 weeks for first 3 doses (prior to study inclusion), every 8 weeks thereafter.

DRUG

Ventolin®

Participants will receive Salbutamol sulfate 100 μg per inhalation as needed.

Sponsors & Collaborators

Principal Investigators

  • Dr. David Jackson · Guy's & St Thomas' NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159519 on ClinicalTrials.gov