Conditions: Allergic Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief summary:
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

Detailed description:
This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.

This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.

Arms:
arm 1: Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) arm 2: Depigoid® (grass/rye pollen 50/50) + Placebo

Interventions: intervention 1: Depigoid intervention 2: Omalizumab intervention 3: Placebo
Intervention descriptions: intervention 1: Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL) intervention 2: anti-IgE (Omalizumab) given during the 2006 core study intervention 3: Placebo given during the 2006 core study

Protocol document: