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

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00482248
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.

Secondary Outcome Measures

Name	Time	Method
Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr