A Multi-Centre Open-Label Study of Mepolizumab in a Subset of Subjects with a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial
ID Number 15-0009Principal Investigator(s)
Gwen S Skloot
Department(s) or Division(s)
Pulmonary, Critical Care and Sleep Medicine
The purpose of this study is to allow subjects to continue to receive the study treatment they received in the existing GlaxoSmithKline (GSK) study MEA115661. The study medication mepolizumab is not approved by the Food and Drug Administration (FDA) for doctors to treat patients with severe asthma and is considered "investigational." Subjects may qualify to take part in this research study, because they have severe asthma, and because they have completed study MEA115661. This study is an extension of the current study MEA115661 (GCO#13-1315).
For a period of up to 116 weeks subjects will undergo a familiar timetable of visits. As with MEA115661 subjects will be asked to return to the clinic every 4 weeks where the same examinations tests and procedures will be performed. Subjects will receive the treatment injection at each visit. This study can stop if the subject decides that they no longer wish to continue the study doctor decides they should no longer continue mepolizumab becomes available to prescribe or GSK is no longer trying to gain approval for mepolizumab to be used in the subject’s country. These visits will occur every 4 weeks for up to 116 weeks or until the subject decides they no longer want to participate their doctor decides they should no longer participate or GSK is no longer trying to market mepolizumab.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 375 people in about 19 countries. Subject participation in this research study is expected to last up to 128 weeks.
Recruiting Patients: No