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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Omalizumab

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, IgE, Omalizumab

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

This study is not being conducted in the United States

Outcomes

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

Full Information

NCT ID

NCT00219323

First Posted

September 21, 2005

Last Updated

October 24, 2011

Sponsor

Novartis

Collaborators

Daiichi Sankyo Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00219323

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

March 2006 (Actual)

Study Completion Date

March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

Collaborators

Daiichi Sankyo Co., Ltd.

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, IgE, Omalizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Primary Outcome Measure Information:

Title

Safety of omalizumab

Secondary Outcome Measure Information:

Title

Pulmonary function parameters measured by spirometer

Title

Morning and evening peak expiratory flow (PEF)

Title

Symptoms score, treatment score, activities of daily living score, nighttime sleep score, and asthma score

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals Japan

Organizational Affiliation

Novartis Pharmaceuticals Japan

Official's Role

Study Chair

Facility Information:

Facility Name

This study is not being conducted in the United States

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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