The efficacy of mepolizumab treatment on rhinovirus induced asthma exacerbations - MATERIA

Academic Medical Center0 个研究点开始时间: 2011年4月27日最近更新: 2013年7月15日

试验速览

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•Age between 18 – 50 years
•Intermittent or mild persistent asthma according to the criteria by the Global Initiative for Asthma
•Non-smoking or stopped smoking more than 12 months ago and = 5 pack years
•Clinically stable, no history of exacerbations within the last 6 weeks prior to the study
•Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 2 weeks prior to the study
•Baseline FEV1 at least 80% of predicted
•PC20histamine < 9.8 mg/ml
•Positive skin prick test to one or more of the 12 common aeroallergen extracts
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Moderate to severe asthma patients (according to the GINA guidelines)
•Patients who have had an exacerbation during the past 6 months, as indicated by a course of systemic steroids or antibiotics
•Presence of antibodies directed against rhinovirus type 16 (titer > 4)
•Smokers or ex-smokers (< 12 months or > 6 pack years)
•Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1
•Patients who are in close contact with young children (< 2 years), either professional or family related
•Participation in any clinical investigational drug treatment protocol within the preceding 3 months

发起方

Academic Medical Center