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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00482508
First received: June 4, 2007
Last updated: October 24, 2011
Last verified: October 2011

June 4, 2007
October 24, 2011
May 2003
October 2005   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00482508 on ClinicalTrials.gov Archive Site
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Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
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

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

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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
Drug: Omalizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
October 2005
October 2005   (final data collection date for primary outcome measure)

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.

Both
12 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00482508
CIGE025IA04E2
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Novartis
Genentech, Inc.
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP