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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482248
First Posted: June 5, 2007
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by:
Novartis
  Purpose
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
Asthma Drug: Omalizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482248


Sponsors and Collaborators
Novartis
Genentech, Inc.
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00482248     History of Changes
Other Study ID Numbers: CIGE0250011E3
First Submitted: June 4, 2007
First Posted: June 5, 2007
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
Asthma
anti-immunoglobulin E
omalizumab
allergic asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents