Official Title: “Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: omalizumab

Primary Measures

• Average daily allergy severity score, calculated from participants' symptom scores

Secondary Measures

• Incidence and severity of adverse events
• number of days with rescue medication (fexofenadine HCl 60 mg) use during the 2003 ragweed season
• number of rescue medication capsules used during the 2003 ragweed season
• rhinoconjunctivitis quality of life (QOL) questionnaire (RQLQ) scores during the 2003 ragweed season
• daily morning allergy symptom scores during the 2003 ragweed season
• daily nighttime allergy symptom scores during the 2003 ragweed season
• individual allergy symptom scores during the 2003 ragweed season

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Overall Clinical Trial Officials and Contacts

Thomas Casale, MD Principal Investigator Creighton University  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00078195

Study ID Number: ITN019AD

ClinicalTrials.gov Identifier: NCT00078195

Health Authority: United States: Food and Drug Administration