Effect of Xolair on Airway Hyperresponsiveness

Study Overview
=================
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.

Official Title
-----------------
The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness

Conditions
-----------------
Allergic Asthma

Intervention / Treatment
-----------------
* Drug: Omalizumab
* Drug: Placebo for Omalizumab
* Drug: omalizumab


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo | Drug: Placebo for Omalizumab<br>* Placebo<br>|
| Experimental: 2<br>Omalizumab | Drug: Omalizumab<br>* 0.016 mg/kg IgE<br>* Other names: rHuMAbE25;Drug: omalizumab<br>* Monoclonal antibody against IgE. 0.016 mg/kg IgE<br>* Other names: rhumabE25;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma