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Effect of Xolair on Airway Hyperresponsiveness

Primary Purpose

Allergic Asthma

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
Placebo for Omalizumab
omalizumab
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring asthma

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Creighton University Division of Allergy & Immunology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

2

Arm Description

Placebo

Omalizumab

Outcomes

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

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

Full Information

First Posted
September 14, 2005
Last Updated
September 22, 2011
Sponsor
Creighton University
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00208234
Brief Title
Effect of Xolair on Airway Hyperresponsiveness
Official Title
The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Omalizumab
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair, rHuMAbE25
Intervention Description
0.016 mg/kg IgE
Intervention Type
Drug
Intervention Name(s)
Placebo for Omalizumab
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
omalizumab
Other Intervention Name(s)
Xolair, rhumabE25
Intervention Description
Monoclonal antibody against IgE. 0.016 mg/kg IgE
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas B Casale, MD
Organizational Affiliation
Creighton University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University Division of Allergy & Immunology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

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Effect of Xolair on Airway Hyperresponsiveness

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