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

Novartis

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00482248

CIGE0250011E3

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)