A multi-center, randomized, double-blind, placebo controlled, parallel group study to compare cessation versus continuation of long-term mepolizumab treatment in patients with severe eosinophilic asthma (201810)

Phase 4

Completed

• Conditions: asthma; bronchial asthma; 10006436

• Registration Number: NL-OMON42751
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

• Asthma is being treated with a controller medication for the past 12 weeks.
• Adequate contraception for females of childbearing potential.

Exclusion Criteria

• Subjects withdrawn from IP or withdrawn from study participation from either MEA115666 or (MEA)201312 for safety reasons.
• Clinically significant deterioration in health status at the completion of participation or EW from either the MEA115666 or 201312 trials which in the opinion of the investigator would make the subject unsuitable for participation in this study.
• Severe or clinically significant cardiovascular disease uncontrolled with standard treatment or QTcF prolongation on ECG, see protocol page 35 for details.
• A current malignancy or previous history of cancer in remission for less than 12 months, see protocol page 35 for details.
• Any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
• Known evidence of lack of adherence within studies MEA115666 or 201312 (less than 80%) to controller medications, scheduled study visits and/or ability to follow physician*s recommendations.
• Current smokers.
• Pregnancy or breastfeeding.
• In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete a questionnaire.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time to first clinically significant exacerbation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Ratio to baseline in blood eosinophil count at weeks 12, 24, 36 and 52. Time to<br /><br>a decrease in asthma control (ACQ-5 score of >= 0.5 units). Time to first<br /><br>exacerbation requiring hospitalization or ED visit.</p><br>