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

This study has been completed.
Daiichi Sankyo Co., Ltd.
Information provided by:
Novartis Identifier:
First received: September 21, 2005
Last updated: October 24, 2011
Last verified: October 2011

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


Condition Intervention Phase
Asthma Drug: Omalizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety of omalizumab

Secondary Outcome Measures:
  • 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

Enrollment: 133
Study Start Date: November 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00219323     History of Changes
Other Study ID Numbers: CIGE025A1307
Study First Received: September 21, 2005
Last Updated: October 24, 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 processed this record on June 23, 2017