Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma

This study has been completed.

First Received: December 19, 2005 Last Updated: May 27, 2008 History of Changes

Sponsor:	Novartis
Collaborators:	Genentech Tanox
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00267202

Purpose

This study is designed to investigate the use of omalizumab as a pretreatment for patients with persistent allergic asthma who are candidates for allergen immunotherapy (ie, allergy shots) and will test the hypothesis that omalizumab may reduce the rate of systemic reactions to immunotherapy in patients with persistent allergic asthma.

Condition	Intervention	Phase
Allergic Asthma	Drug: omalizumab	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 26-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Multi-Center Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Systemic allergic reactions to immunotherapy

Secondary Outcome Measures:

Severity of allergic reaction
Time to reach maintenance immunotherapy dose
Number of patients who reach maintenance immunotherapy dose
Doses of rescue medication

Estimated Enrollment:	600
Study Start Date:	December 2005
Study Completion Date:	April 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Allergic asthma (persistent symptoms while receiving inhaled corticosteroids)
Elevated serum IgE
Allergy (sensitivity) to perennial allergens (cat, dog, and/or house dust mite)

Exclusion Criteria:

Severe asthma
Current use of allergy shots (immunotherapy)
History of anaphylaxis (except foods or stinging insects)

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267202

Locations

United States, New Jersey
Novartis
East Hanover, New Jersey, United States

Sponsors and Collaborators

Novartis

Genentech

Tanox

Investigators

Study Chair:

Novartis

More Information

Additional Information:

Novartis patient recruitment website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CIGE025AUS23
Study First Received:	December 19, 2005
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00267202 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Allergic Asthma, IgE, immunotherapy, omalizumab

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on February 08, 2010