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
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
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.
Inclusion Criteria:
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
Exclusion Criteria:
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)
Smokers
Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year
Other protocol-defined inclusion/exclusion criteria may apply.
Ste-Foy, Quebec G1V 4G5, Canada