Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Collaborator: Genentech, Inc.
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events

• Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee

Exclusion Criteria:

• Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3

• Pregnant females or nursing mothers

• Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs

Other protocol-defined inclusion/exclusion criteria may apply