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Clinical Trials/NCT00482248
NCT00482248
Completed
Phase 3

An Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Adults and Adolescents With Severe Allergic Asthma Who Participated in the 52 Week CIGE250011E2 Study

Novartis0 sites132 target enrollmentJune 2003
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ConditionsAsthma
DrugsOmalizumab

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Asthma
Sponsor
Novartis
Enrollment
132
Primary Endpoint
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.
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2003
End Date
June 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis

Eligibility Criteria

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

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