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

This study has been completed.
Genentech, Inc.
Information provided by:
Novartis Identifier:
First received: June 4, 2007
Last updated: October 24, 2011
Last verified: October 2011
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.

Condition Intervention Phase
Drug: Omalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 132
Study Start Date: June 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00482248

Sponsors and Collaborators
Genentech, Inc.
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information Identifier: NCT00482248     History of Changes
Other Study ID Numbers: CIGE0250011E3 
Study First Received: June 4, 2007
Last Updated: October 24, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Italy: Direzione Generale di Sanità Veterinaria e degli Alimenti
Russia: Ministry of Public Health
Sweden: Medical Products Agency
Netherlands: Medicines Evaluation Board (MEB)
Czech Republic: State Institute for Drug Control
United Kingdom: Medical and Healthcare Products Regulatory Agency (MHRA)

Keywords provided by Novartis:
anti-immunoglobulin E
allergic asthma

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses processed this record on May 04, 2016