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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00546143
First received: October 17, 2007
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  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
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:

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov 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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 22, 2013