Study of Omalizumab in Moderate to Severe Bronchial Asthma

This study has been completed.
Daiichi Sankyo Co., Ltd.
Information provided by:
Novartis Identifier:
First received: October 3, 2005
Last updated: October 24, 2011
Last verified: October 2011

This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.

Condition Intervention Phase
Drug: Omalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Study of Omalizumab in Moderate to Severe Bronchial Asthma

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Pulmonary function parameters measured by spirometer
  • Frequency of rescue medication use
  • Symptom score
  • Activities of daily living score
  • Nighttime sleep score

Enrollment: 327
Study Start Date: October 2002
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both

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 identifier: NCT00232050

Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan
  More Information

No publications provided Identifier: NCT00232050     History of Changes
Other Study ID Numbers: CIGE025A1304
Study First Received: October 3, 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:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents processed this record on April 21, 2014