Trial name or title |
Cessation versus continuation of long‐term mepolizumab in severe eosinophilic asthma patients |
Methods |
Multi‐center, randomised, double‐blind, placebo‐controlled, parallel‐group study |
Participants |
300 participants
Asthma is currently being treated with a controller medication and the participant has been on a controller medication for the past 12 weeks. Participants will be expected to continue controller therapy for the duration of the study.
Male or eligible female participants
|
Interventions |
Mepolizumab 100 mg versus placebo |
Outcomes |
Primary outcome measures
Time to first clinically significant exacerbation )(time frame: up to 52 week)]
Secondary outcome measures
Ratio to baseline in blood eosinophil count (time frame: baseline (week 0) and up to week 52)
Time to a decrease in asthma control, defined as an increase from baseline in Asthma Control Questionnaire‐5 (ACQ‐5) score of ≥ 0.5 units
Time to first exacerbation requiring hospitalisation or ED visit (time frame: up to 52 weeks)
|
Starting date |
January 2016 |
Contact information |
US GSK Clinical Trials Call Center GSKClinicalSupportHD@gsk.com |
Notes |
Estimated study completion date: January 2019 |