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Study of Omalizumab in Moderate to Severe Bronchial Asthma

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00232050
First received: October 3, 2005
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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
Asthma
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)
  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
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 ClinicalTrials.gov identifier: NCT00232050

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: 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:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014