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

Novartis132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Asthma

Interventions

OmalizumabDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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