A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study

Novartis0 sites95 target enrollmentMay 2003

ConditionsAsthma

DrugsOmalizumab

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Asthma
Sponsor: Novartis
Enrollment: 95
Primary Endpoint: 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
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

October 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

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