Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Antibodies, Monoclonal
Omalizumab
Criteria
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.