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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00078195 |
Purpose
A series of allergy shots may reduce symptoms of seasonal ragweed allergies. This study will determine whether taking a drug called omalizumab (also known as Xolair) before getting the allergy shots is more effective than allergy shots alone or other treatments, such as prescription antihistamines.
| Condition | Intervention | Phase |
|---|---|---|
|
Hay Fever Hypersensitivity Allergy Rhinitis |
Drug: omalizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody |
| Estimated Enrollment: | 168 |
| Study Start Date: | April 2003 |
Allergic rhinitis affects 20 to 40 million Americans annually. Allergy symptoms, which can range from mild to seriously debilitating, may affect quality of life. Left untreated, allergic rhinitis can exacerbate or trigger more serious conditions, such as asthma and sinus inflammation.
Individuals with allergies react to harmless particles such as dust or pollen. Proteins in the blood called IgE antibodies treat the harmless particles as invaders and trigger an immune system response. The immune response results in harmful inflammation of healthy tissues. In ragweed allergy, inflammation occurs in the airways and causes familiar allergy symptoms like sneezing, coughing, and general discomfort.
Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies. The blocking effect of omalizumab is temporary, but giving the drug to people before their regular allergy shots may make the shots more effective.
Participants in this study will be randomly assigned to receive injections of omalizumab or a placebo before an accelerated course of allergy shots (given over 12 weeks). The participants will return for follow-up for up to one year, and they may have as many as 27 study visits.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Nebraska | |
| Creighton University | |
| Omaha, Nebraska, United States, 68131 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53705 | |
| Principal Investigator: | Thomas Casale, MD | Creighton University |
More Information
| Study ID Numbers: | DAIT ITN019AD |
| Study First Received: | February 19, 2004 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00078195 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Ragweed Immunotherapy Rush Immunotherapy |
RIT Hayfever Seasonal Allergic Rhinitis |
|
Otorhinolaryngologic Diseases Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Fever Antibodies, Monoclonal Hypersensitivity Antibodies |
Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Respiratory Hypersensitivity Omalizumab Immunoglobulins |
|
Respiratory System Agents Otorhinolaryngologic Diseases Immune System Diseases Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Pharmacologic Actions Nose Diseases |
Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity Omalizumab |
