Effect of Xolair on Airway Hyperresponsiveness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2011 by Creighton University.
Recruitment status was: Active, not recruiting

Sponsor:

Collaborator:

Genentech, Inc.

Information provided by (Responsible Party):

Creighton University

ClinicalTrials.gov Identifier:

NCT00208234

First received: September 14, 2005

Last updated: September 22, 2011

Last verified: September 2011

History of Changes

Purpose

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	Intervention	Phase
Allergic Asthma	Drug: Omalizumab Drug: Placebo for Omalizumab Drug: omalizumab	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness

Resource links provided by NLM:

Genetics Home Reference related topics: allergic asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:

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:

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 ]


Estimated Enrollment:	22
Study Start Date:	January 2004
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208234

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


Responsible Party:	Creighton University
ClinicalTrials.gov Identifier:	NCT00208234 History of Changes
Other Study ID Numbers:	Xolair Asthma
Study First Received:	September 14, 2005
Last Updated:	September 22, 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

ClinicalTrials.gov processed this record on June 28, 2017

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