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

Tracking Information

First Received Date ^ICMJE

February 19, 2004

Last Updated Date

May 13, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00078195 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered With Omalizumab, an Anti-IgE Monoclonal Antibody

Brief 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.

Detailed Description

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hay Fever
Hypersensitivity
Allergy
Rhinitis

Intervention ^ICMJE

Drug: omalizumab

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

168

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00078195

Responsible Party

Study ID Numbers ^ICMJE

DAIT ITN019AD

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Immune Tolerance Network

Investigators ^ICMJE

Principal Investigator:

Thomas Casale, MD

Creighton University

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP