Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients

Novartis95 enrolled

Overview

This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

OmalizumabDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who completed core study and extension study CIGE24IA05E1 up to and including visit 15, without experiencing any significant drug-related adverse events * Patients who have given written informed consent Exclusion Criteria: * Patients who had not received study medication for greater than 84 days since visit 15 of study CIGE24IA05E1 * 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, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total

Data from ClinicalTrials.gov

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