A TWO-PART, RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTI-CENTER STUDY TO INVESTIGATE THE USE OF MEPOLIZUMAB (SB-240563) IN REDUCING THE NEED FOR SURGERY IN SUBJECTS WITH SEVERE BILATERAL NASAL POLYPOSIS

GlaxoSmithKline Research & Development Limited0 个研究点目标入组 110 人2009年2月27日

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暂无简介。

注册库

who.int

开始日期

2009年2月27日

结束日期

待定

最后更新

11年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\. Subjects have a diagnosis of severe bilateral nasal polyposis at the screening
•visit and Visit 1 (i.e. at end of run\-in period) which meets the definition of the
•situation indicative of the need for surgery.
•2\. Subjects must have had at least one previous surgery for the removal of nasal
•3\. Subjects must have an history of refractory response to steroid therapy as
•shown by being deemed potentially eligible for surgery.
•4\. Male or female between 18 and 70 years of age, inclusive.
•5\. BMI within the range 19\.0 to 31\.0 kg/m2 (inclusive).
•6\. Subjects must be free of any clinically significant disease that would interfere
•with the study schedule or procedures or compromise his/her safety.

•1\. As a result of medical interview, physical examination, or screening investigation
•the physician responsible considers the subject unfit for the study.
•2\. Subjects who have required a burst of oral corticosteroids within 1 month prior
•to Screening.
•3\. Subjects who have had an asthma exacerbation requiring admission to hospital
•within 4 weeks of Screening.
•4\. Subjects who have received immunotherapy within the previous 12 months.
•5\. Subjects with a positive pre\-study drug/alcohol screen.
•6\. Subjects who are currently receiving, or have received within 3 months prior to
•first mepolizumab dose, chemotherapy, radiotherapy or investigational