Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
This study assessed the effect on asthma control of different dose levels and regimens of
 QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2
 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab.
 Information from this study was planned to support the design of future studies.
Key Inclusion Criteria:

 -  A diagnosis of allergic asthma , uncontrolled on current medication.

 -  History of at least 1 asthma exacerbation during the last 1 year

 -  Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted
 normal value; reversibility following administration of bronchodilator must also be
 demonstrated (historical positive reversibility or bronchoprovocation result can be
 used).

 Key Exclusion Criteria:

 -  Baseline IgE levels or body weight outside the omalizumab dosing table.

 -  Use of tobacco products within the previous 6 months (Social occasional smokers may be
 included).

 -  Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.