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Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis

Allergic Asthma Clinical Trial

Official title:
A Randomized, 20 Week, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Combination With Depigoid, Versus Depigoid Only, in Adult and Adolescent Patients With Seasonal Allergic Asthma and Comorbid Seasonal Allergic Rhinoconjunctivitis - Open-label Depigoid Monotherapy Extension Periods 2007 and 2008-

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00396409
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date February 2006
Completion date August 2008
View Details
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