Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

Novartis

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546143

CIGE025A2208

Details and patient eligibility

About

This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of allergic asthma >= 1 year duration and a history consistent with Step 2 or 3 clinical features from the Global Initiative for Asthma guidelines.
• Eligible baseline serum immunoglobulin E (IgE) levels value and body-weight combinations

Exclusion criteria

• Documented medical history of anaphylaxis
• Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD)

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

1

Experimental group

Description:

Omalizumab 900 mg

Treatment:

Drug: Omalizumab

Drug: Omalizumab

Drug: Omalizumab

2

Experimental group

Description:

Omalizumab 1050 mg

Treatment:

Drug: Omalizumab

Drug: Omalizumab

Drug: Omalizumab

3

Experimental group

Description:

Omalizumab 1200 mg

Treatment:

Drug: Omalizumab

Drug: Omalizumab

Drug: Omalizumab