A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels

This study has been completed.

First Received: February 18, 2008 Last Updated: February 11, 2009 History of Changes

Sponsors and Collaborators:	Novartis Genentech Tanox
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00624832

Purpose

This study will demonstrate that patients with standard and high IgE levels can be protected from allergen induced broncho-constriction by Xolair

Condition	Intervention	Phase
Asthma	Drug: Xolair Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy of Xolair in an Allergen Bronchoprovocation Study in Asthmatic Populations Defined by Serum IgE Concentrations

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:

Change in early phase allergic response after treatment with study drug in active vs. placebo patients [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Change in late phase allergic response after treatment with study drug in active vs. placebo patients [ Time Frame: throughout the study ]

Estimated Enrollment:	58
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Xolair
2: Experimental	Drug: Xolair
3: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male and female adult patients aged 18-65 years (inclusive)
Patients diagnosed with asthma with FEV1 ≥65% of the predicted normal value for the patient.
Body weight between 40-150kg
Positive skin prick test t a specific allergen

Exclusion Criteria:

Current active smokers
Patients who have been hospitalized or had emergency treatment for an asthma attack in the 12 months prior to study start
History of bleeding disorders
History of drug allergy
Pregnant women or nursing mothers
Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
Sexually active males who have not been sterilized and are not using a condom
History of immunocompromise, including a positive HIV
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
History of drug or alcohol abuse within 12 months of study start

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624832

Locations

Germany
Novartis Investigator Site
Frankfurt, Germany
Novartis Investigator Site
Berlin, Germany
Novartis Investigator Site
Munich, Germany
Netherlands
Novartis Investigator Site
Groningen, Netherlands
South Africa
Novartis Investigator Site
Bloemfontein, South Africa
Novartis Investigator Site
Durban, South Africa

Sponsors and Collaborators

Novartis

Genentech

Tanox

Investigators

Principal Investigator:

Novartis

Novartis investigator site

More Information

No publications provided

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CIGE025A2210
Study First Received:	February 18, 2008
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00624832 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

Asthma
allergen challenge
bronchoprovocation
Methacholine challenge

serum Immunoglobulin E
Nitric Oxide
skin prick test

Study placed in the following topic categories:

Bronchial Diseases
Asthma
Nitric Oxide
Lung Diseases, Obstructive
Hypersensitivity
Antibodies
Respiratory Tract Diseases

Lung Diseases
Methacholine Chloride
Hypersensitivity, Immediate
Respiratory Hypersensitivity
Omalizumab
Immunoglobulins

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 04, 2009