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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: October 17, 2007
Last updated: September 1, 2010
Last verified: September 2010
This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

Condition Intervention Phase
Drug: Omalizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Open-label, Multiple Dose Study in Mild to Moderate Asthmatics (With IgE/Body Weight Combinations Above That in the SmPC Dosing Table) to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Omalizumab

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of omalizumab assessed by AEs and SAEs

Secondary Outcome Measures:
  • - Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels

Enrollment: 32
Study Start Date: July 2007
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Omalizumab 900 mg
Drug: Omalizumab
Other Name: Xolair, IGE025
Experimental: 2
Omalizumab 1050 mg
Drug: Omalizumab
Other Name: Xolair, IGE025
Experimental: 3
Omalizumab 1200 mg
Drug: Omalizumab
Other Name: Xolair, IGE025


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00546143

Novartis Investigative Site
Berlin, Germany
Novartis Investigative site
Hamburg, Germany
Novartis investigative site
Hannover, Germany
Novartis investigative site
Mainz, Germany
South Africa
Novartis Investigative site
Bloemfontein, South Africa
Sponsors and Collaborators
Principal Investigator: Novartis Novartis investigative site
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00546143     History of Changes
Other Study ID Numbers: CIGE025A2208 
Study First Received: October 17, 2007
Last Updated: September 1, 2010
Health Authority: Germany: Paul-Ehrlich-Institut
South Africa: Medicines Control Council

Keywords provided by Novartis:
Asthma, anti-immunoglobulin E, omalizumab

Additional relevant MeSH terms:
Anti-Allergic Agents
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses processed this record on February 11, 2016