MEA115661: A multi-centre, open-label, long-term safety study of mepolizumab in asthmatic subjects who participated in the MEA115588 or MEA115575 trials

Phase 3

Completed

• Conditions: asthma; bronchial asthma; 10006436

• Registration Number: NL-OMON39006
• Lead Sponsor: GlaxoSmithKline BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

* Completion of the double-blind treatment during MEA115588 or MEA115575.
* Current treatment with an additional controller medication for the past 12 weeks.
* Adequate contraception during the study and the following 4 months for females of childbearing potential.

Exclusion Criteria

* A study related SAE in MEA115588 or MEA115575 that was assessed as possibly related to study medication by the investigator
* Pregnancy or breastfeeding
* Current smokers.
* Baseline ECG which has a clinically significant abnormality or which shows QTcF prolongation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Antibodies, exacerbations, asthma control questionnaire, FEV1, no. of<br /><br>withdrawals, hospitalizations, safety tests (ECG, lab etc.).</p><br>