Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma

A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy

This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.

Inclusion Criteria:

Severe persistent asthma with the following characteristics:

• Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
• Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
• Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens

Exclusion Criteria:

• Current smokers or smoking history stopped for less than 3 years or > 10 pack years.
• Asthma exacerbation during the 4 weeks prior to randomization.
• Active lung disease other than non-atopic asthma.
• Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
• Pregnant or nursing (lactating) women.
• Treatment with omalizumab.

Other protocol-defined inclusion/exclusion criteria may apply