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

September 21, 2005
September 22, 2005
October 25, 2011
November 2003
March 2006   (Final data collection date for primary outcome measure)
Safety of omalizumab
Not Provided
Complete list of historical versions of study NCT00219323 on ClinicalTrials.gov Archive Site
  • Pulmonary function parameters measured by spirometer
  • Morning and evening peak expiratory flow (PEF)
  • Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score
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Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.
Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma

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

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
Drug: Omalizumab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
Not Provided
March 2006
March 2006   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00219323
CIGE025A1307
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Novartis
Daiichi Sankyo Co., Ltd.
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan
Novartis
October 2011

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