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NCT00219323 Clinical Trial

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

Asthma Clinical Trial

Official title:
Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219323
Other study ID # CIGE025A1307
Secondary ID
Status Completed
Phase Phase 3
First received September 21, 2005
Last updated October 24, 2011
Start date November 2003
Est. completion date March 2006

Study information
Verified date October 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 133
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers
Gender Both
Age group 20 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Omalizumab

Locations
Country Name City State
Japan This study is not being conducted in the United States Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Novartis Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of omalizumab
Secondary Pulmonary function parameters measured by spirometer
Secondary Morning and evening peak expiratory flow (PEF)
Secondary Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score
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