Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

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. Identifier: NCT00219323
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 25, 2011
Daiichi Sankyo Co., Ltd.
Information provided by:

Brief Summary:

This study will evaluate the safety and efficacy of omalizumab up to 48 weeks in adult patients with moderate to severe bronchial asthma.


Condition or disease Intervention/treatment Phase
Asthma Drug: Omalizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma
Study Start Date : November 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab

Primary Outcome Measures :
  1. Safety of omalizumab

Secondary Outcome Measures :
  1. Pulmonary function parameters measured by spirometer
  2. Morning and evening peak expiratory flow (PEF)
  3. Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Allergic asthma patients
  • Inadequately controlled patients

Exclusion Criteria:

  • - History of severe anaphylactoid or anaphylactic reactions
  • Previous treatment with omalizumab
  • History of cancer or cancer

Other protocol-defined exclusion criteria may apply.

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 identifier (NCT number): NCT00219323

This study is not being conducted in the United States
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan Identifier: NCT00219323     History of Changes
Other Study ID Numbers: CIGE025A1307
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Novartis:
Asthma, IgE, Omalizumab

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