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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219323

Enrollment

133

Registered

2005-09-22

Start date

2003-11-30

Completion date

2006-03-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, IgE, Omalizumab

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

Interventions

DRUGOmalizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Safety of omalizumab	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026