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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00546143
First Posted: October 18, 2007
Last Update Posted: September 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

Condition Intervention Phase
Asthma Drug: Omalizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546143


Locations
Germany
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
Novartis
Investigators
Principal Investigator: Novartis Novartis investigative site
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00546143     History of Changes
Other Study ID Numbers: CIGE025A2208
First Submitted: October 17, 2007
First Posted: October 18, 2007
Last Update Posted: September 2, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs