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

Phase 3CompletedNCT00219323

Novartis133 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

Asthma

Interventions

OmalizumabDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

This study is not being conducted in the United States

Tokyo, Japan

Outcomes

Primary Outcomes

Safety of omalizumab

Secondary Outcomes

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

Data from ClinicalTrials.gov

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