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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219323
First Posted: September 22, 2005
Last Update Posted: October 25, 2011
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.
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Novartis
  Purpose

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


Condition Intervention Phase
Asthma Drug: Omalizumab Phase 3

Study Type: Interventional
Study Design: 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

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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00219323


Locations
Japan
This study is not being conducted in the United States
Tokyo, Japan
Sponsors and Collaborators
Novartis
Daiichi Sankyo Co., Ltd.
Investigators
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan
  More Information

ClinicalTrials.gov Identifier: NCT00219323     History of Changes
Other Study ID Numbers: CIGE025A1307
First Submitted: September 21, 2005
First Posted: September 22, 2005
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Novartis:
Asthma, IgE, Omalizumab

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