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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00219323
First received: September 21, 2005
Last updated: October 24, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety/Efficacy Study
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)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00219323     History of Changes
Other Study ID Numbers: CIGE025A1307
Study First Received: September 21, 2005
Last Updated: October 24, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014