drugset / Trial / NCT00078195
Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies
Phase 2
Completed
168 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2003-04
- Primary completion
- 2005-05
- Completion
- 2005-05
Publications
- Results Nayak A, Casale T, Miller SD, Condemi J, McAlary M, Fowler-Taylor A, Della Cioppa G, Gupta N. Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2003 Sep-Oct;24(5):323-9.
- Results Casale TB, Busse WW, Kline JN, Ballas ZK, Moss MH, Townley RG, Mokhtarani M, Seyfert-Margolis V, Asare A, Bateman K, Deniz Y; Immune Tolerance Network Group. Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis. J Allergy Clin Immunol. 2006 Jan;117(1):134-40. doi: 10.1016/j.jaci.2005.09.036. Epub 2005 Dec 2.
- Results Klunker S, Saggar LR, Seyfert-Margolis V, Asare AL, Casale TB, Durham SR, Francis JN; Immune Tolerance Network Group. Combination treatment with omalizumab and rush immunotherapy for ragweed-induced allergic rhinitis: Inhibition of IgE-facilitated allergen binding. J Allergy Clin Immunol. 2007 Sep;120(3):688-95. doi: 10.1016/j.jaci.2007.05.034. Epub 2007 Jul 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 0.016 mg/kg | Subcutaneous |
| Subject | Ragweed immunotherapy (IT) | Unknown | — | — |
| Subject | Ragweed rush immunotherapy (RIT) | Unknown | 0.3 ml | — |