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Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies - Article


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Allergy

Allergies; Allergy/Allergies; Anaphylaxis


Clinical Trial: Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies

This study is no longer recruiting patients.

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)

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 Treatment or Intervention Phase
Hay Fever
Hypersensitivity
Allergy
Rhinitis
 Drug: omalizumab
Phase II

MedlinePlus related topics:  Allergy;   Nose Disorders;   Respiratory Diseases

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

Further Study Details: 

Expected Total Enrollment:  168

Study start: 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   -   50 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

  • History of seasonal allergic rhinitis
  • Intend to stay in a ragweed pollen area during the ragweed season
  • Baseline serum IgE level between 10 and 700 IU/ml
  • General good health

Exclusion Criteria

  • Current smoker
  • Pregnancy
  • Asthma
  • Certain medications
  • History of anaphylactoid or anaphylactic reactions
  • History of cancer, except for basal cell carcinoma

Location Information


Iowa
      University of Iowa, Iowa City,  Iowa,  52242,  United States

Nebraska
      Creighton University, Omaha,  Nebraska,  68131,  United States

Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53705,  United States

Study chairs or principal investigators

Thomas Casale, MD,  Principal Investigator,  Creighton University   

More Information

Study ID Numbers:  ITN019AD
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  February 19, 2004
ClinicalTrials.gov Identifier:  NCT00078195
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 9, 2005
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