Effect of Xolair on Airway Hyperresponsiveness

Study Description

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Brief Summary:

The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Condition or disease	Intervention/treatment	Phase
Allergic Asthma	Drug: Omalizumab; Drug: Placebo for Omalizumab; Drug: omalizumab	Phase 4

Detailed Description:

Xolair, a recombinant humanized monoclonal anti-IgE antibody, has been studied extensively and proven efficacious in the treatment of asthma and other allergic disorders. In moderate to severe allergic asthmatic patients, Xolair reduced asthma exacerbations and improved symptoms. However, there is limited data on the effects of Xolair on airway hyperreactivity, an important component of asthma.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	22 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness
Study Start Date :	January 2004
Estimated Primary Completion Date :	September 2011
Estimated Study Completion Date :	September 2011

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Control; Placebo	Drug: Placebo for Omalizumab; Placebo
Experimental: 2; Omalizumab	Drug: Omalizumab; 0.016 mg/kg IgE; Other Names: Xolair; rHuMAbE25 Drug: omalizumab; Monoclonal antibody against IgE. 0.016 mg/kg IgE; Other Names: Xolair; rhumabE25

Outcome Measures

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Primary Outcome Measures :

1. To determine if treatment with omalizumab induces changes in PC20 values to methacholine bronchoprovocation challenges and/or PC15 values to hypertonic saline-induced bronchoprovocation challenges in a time-dependent manner in steroid naive subjects [ Time Frame: post treatment ]

Secondary Outcome Measures :

1. Determine in steroid naive allergic asthma subjects whether omalizumab decreases exhaled NO and sputum eosinophilia, markers of airway inflammation, in time-dependent fashion and to correlate these effects with those measured for airway responsiveness [ Time Frame: post treatment ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Female patients must have a negative urine pregnancy test at Visit 1 and a negative urine pregnancy test at subsequent visits. In addition, female patients must be using a medically acceptable form of birth control.
• History of mild to moderate asthma
• A positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagoides farinae, or dermatophagoides pteronyssinus)
• A PC20 value for methacholine < 5 mg/mL
• A PC15 value for hypertonic saline at < 4 minutes
• Capable of faithfully attending regularly scheduled study visits
• Willing to avoid prohibited medications for the periods indicated in the protocol
• A baseline serum IgE level of > 30 IU/mL and < 700 IU/mL

Exclusion Criteria:

• Women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding
• Known sensitivity to study drug or class of study drug
• Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit
• Patients with a history of severe anaphylactoid or anaphylactic reactions
• Patients taking beta-adrenergic antagonists in any form
• Patients previously exposed to Xolair
• Patients with a known hypersensitivity to trial drug excipient ingredients or related drugs
• Chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations
• Use of immunosuppressive medications
• History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Nebraska
Creighton University Division of Allergy & Immunology
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Genentech, Inc.

Investigators

Principal Investigator:	Thomas B Casale, MD	Creighton University Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Creighton University
ClinicalTrials.gov Identifier:	NCT00208234 History of Changes
Other Study ID Numbers:	Xolair Asthma
First Posted:	September 21, 2005
Last Update Posted:	September 23, 2011
Last Verified:	September 2011

Keywords provided by Creighton University:

asthma

Additional relevant MeSH terms:

Respiratory Hypersensitivity; Respiratory Tract Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Omalizumab	Antibodies, Monoclonal; Anti-Allergic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Immunologic Factors; Physiological Effects of Drugs