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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482508
First Posted: June 5, 2007
Last Update Posted: October 25, 2011
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 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

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: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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

Enrollment: 95
Study Start Date: May 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  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): NCT00482508


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

ClinicalTrials.gov Identifier: NCT00482508     History of Changes
Other Study ID Numbers: CIGE025IA04E2
First Submitted: June 4, 2007
First Posted: June 5, 2007
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Novartis:
Asthma
anti immunoglobulin E
omalizumab

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