Study of Omalizumab in Moderate to Severe Bronchial Asthma

Phase 3CompletedNCT00232050

Novartis327 enrolled

Overview

This study will evaluate the safety and efficacy of omalizumab up to 16 weeks in adult patients with moderate to severe bronchial asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

327

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

Outcomes

Primary Outcomes

Morning peak expiratory flow (PEF) at baseline and end of treatment.

Secondary Outcomes

Pulmonary function parameters measured by spirometer

Frequency of rescue medication use

Symptom score

Activities of daily living score

Nighttime sleep score

Data from ClinicalTrials.gov

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