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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Omalizumab

• Registration Number: NCT00546143
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-18
• Primary Completion: 2008-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Omalizumab	Omalizumab 1200 mg
1	Omalizumab	Omalizumab 900 mg
2	Omalizumab	Omalizumab 1050 mg

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of omalizumab assessed by AEs and SAEs

Secondary Outcome Measures

Name	Time	Method
- Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels

Trial Locations

Locations (3)

Novartis Investigative Site; 🇩🇪 Berlin, Germany

Novartis Investigative site; 🇿🇦 Bloemfontein, South Africa

Novartis investigative site; 🇩🇪 Mainz, Germany