Effect of Xolair on Airway Hyperresponsiveness
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ClinicalTrials.gov Identifier: NCT00208234 |
Recruitment Status
: Unknown
Verified September 2011 by Creighton University.
Recruitment status was: Active, not recruiting
First Posted
: September 21, 2005
Last Update Posted
: September 23, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Asthma | Drug: Omalizumab Drug: Placebo for Omalizumab Drug: omalizumab | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Control
Placebo
|
Drug: Placebo for Omalizumab
Placebo
|
Experimental: 2
Omalizumab
|
Drug: Omalizumab
0.016 mg/kg IgE
Other Names:
Drug: omalizumab
Monoclonal antibody against IgE. 0.016 mg/kg IgE
Other Names:
|
- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208234
United States, Nebraska | |
Creighton University Division of Allergy & Immunology | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Thomas B Casale, MD | Creighton University Medical Center |
Responsible Party: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00208234 History of Changes |
Other Study ID Numbers: |
Xolair Asthma |
First Posted: | September 21, 2005 Key Record Dates |
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 |