MEA115588 A randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe uncontrolled refractory asthma - Efficacy of Mepolizumab in Severe Asthma

GlaxoSmithKline Research and Development Limited0 个研究点目标入组 540 人2013年1月15日

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注册库

who.int

开始日期

2013年1月15日

结束日期

待定

最后更新

13年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

GlaxoSmithKline Research and Development Limited

•Subjects eligible for enrolment in the study and entry into the run\-in period must meet all of the following criteria:
•1\. Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
•2\. Age: At least 12 years of age at visit 1 and a minimum weight of 45kg \[For those countries where local regulations permit enrolment of adults only, subject recruitment will be restricted to those who are \= 18 years of age]
•3\. Inhaled Corticosteroid: A well\-documented requirement for regular treatment
•with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with
•or without maintenance oral corticosteroids (OCS). \[Maintenance OCS is defined
•as a prescribed regimen of a minimum average daily dose of prednisone 5mg (or
•equivalent)].
•For 18 years of age and older:
•ICS dose must be \=880 mcg/day fluticasone propionate (FP) (exactuator)

•Subjects meeting any of the following criteria must not be enrolled in the study:
•1\. Smoking history: Current smokers or former smokers with a smoking history of \=10 pack years (number of pack years \= (number of cigarettes per day / 20\) x
•number of years smoked). A former smoker is defined as a subject who quit
•smoking at least 6 months prior to Visit 1\.
•2\. Concurrent Respiratory Disease: Presence of a known pre\-existing, clinically
•important lung condition other than asthma. This includes current infection,
•bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
•3\. Malignancy: A current malignancy or previous history of cancer in remission for
•less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded). \[Note for South Korea: Korean subjects with a diagnosis of malignancy within 5 years are excluded]
•4\. Liver Disease: Known, pre\-existing, unstable liver disease (as defined by the