A randomized, double-blind, placebo- and comparator-controlled study evaluating the effect of multiple doses of QGE031 compared to omalizumab in asthma induced by allergen bronchial provocation

ovartis Pharma Services AG0 个研究点目标入组 40 人开始时间: 2012年10月19日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•Adult patients 18 to 65 years
•Positive skin prick test to one or more common airborne allergens
•Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL
•Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1
•Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab
•Additional inclusion criteria may apply.
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnant or nursing (lactating) women.
•Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol)
•Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year
•Additional exclusion criteria may apply.

发起方