Study of Omalizumab 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: NCT00232050
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : October 25, 2011
Daiichi Sankyo Co., Ltd.
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Brief Summary:
This study will evaluate the safety and efficacy of omalizumab up to 16 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 : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Study of Omalizumab in Moderate to Severe Bronchial Asthma
Study Start Date : October 2002
Primary Completion Date : May 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Primary Outcome Measures :
  1. Morning peak expiratory flow (PEF) at baseline and end of treatment.

Secondary Outcome Measures :
  1. Pulmonary function parameters measured by spirometer
  2. Frequency of rescue medication use
  3. Symptom score
  4. Activities of daily living score
  5. Nighttime sleep score

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
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): NCT00232050

Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan Identifier: NCT00232050     History of Changes
Other Study ID Numbers: CIGE025A1304
First Posted: October 4, 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