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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hay Fever, Hypersensitivity, Allergy, Rhinitis

In brief

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.

Key facts

Study ID

NCT00078195

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

168

Starts

2003-04-01

Expected to finish

2005-05-01

Last updated by the study team

2016-10-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to comprehend and grant a witnessed, written informed consent prior to any study procedures.
• Female participants of child bearing age must have a negative urine pregnancy test at Screening Visit and subsequent visits. In addition, female participants must be using a medically acceptable form of birth control.
• History of seasonal allergic rhinitis for at least 2 years with symptoms during the ragweed pollen season requiring pharmacotherapy.
• A positive skin test by prick method to ragweed pollen at the Screening Visit. A positive skin prick test will be defined as a ragweed pollen-induced wheal greater than 3 mm larger in diameter than diluent control (measurements will be made 15-20 minutes after application).
• Must be capable of faithfully completing the diary and of attending regularly scheduled study visits.
• Must intend to remain in the ragweed pollen area during the entire ragweed season.
• Willing to avoid prohibited medications for the periods indicated in the protocol.
• Participants must meet pretrial eligibility requirements for trial enrollment (acceptable medical history, physical examination results, normal electrocardiogram and acceptable laboratory test results).
• Participants must have a baseline serum Immunoglobulin E (IgE) level greater than 10 and less than 700 IU/mL.

You may not qualify if…

• weigh less than 30 kg or more than 120 kg.
• pregnant or lactating.
• history of severe anaphylactoid (non-IgE mediated) or anaphylactic reactions).
• history of immunotherapy within the past 10 years, if received one full year of immunotherapy, or within the past 5 years if received less than one year of immunotherapy.
• known hypersensitivity to trial rescue medication (fexofenadine HCl).
• taking beta-adrenergic antagonists in any form.
• taking allergic ophthalmologic medication.
• clinically significant perennial rhinitis that would interfere in assessment of ragweed-induced seasonal allergic rhinitis symptoms.
• Presence of a severely deviated nasal septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction.
• History of an upper respiratory or sinus infection requiring treatment with an antibiotic within 2 weeks prior to Screening Visit.
• Documented evidence of acute or significant chronic sinusitis, as determined by the Investigator.
• Asthma (either history of, abnormal spirometry, [forced expiratory volume in 1 second (FEV1) less than 80% predicted] or use of asthma medications).
• Chronic or intermittent use of inhaled, oral, intra-muscular, or intra-venous corticosteroids; or chronic or intermittent use of topical corticosteroids within 4 weeks of Visit Screening Visit.
• Chronic use of medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication.
• Rhinitis medicamentosa.
• History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal or other significant medical condition including, autoimmune or collagen vascular disorders, aside from organ-specific autoimmune disease limited to the thyroid that in the Investigator's opinion could interfere with the study or require medical treatment that would interfere with the study.
• History of cancer other than basal cell carcinoma of the skin.
• History within the past year of excessive alcohol intake or drug addiction.
• Current smokers, greater than 10 pack year history, or participants who quit smoking less than one year prior to Screening.
• Use of any prohibited concomitant medications during the washout period (i.e., before screening) and throughout the study period.
• Participants currently undergoing immunotherapy.
• Participants with clinically significant abnormality on 12-lead Electrocardiogram (ECG) on screening visit.
• Treatment with an experimental, non-approved drug, or investigational drug within the past 30 days.
• Participants with a history of noncompliance to medical regimens and participants who are considered potentially unreliable.
• Previous treatment with a monoclonal antibody for any reason including anti-IgE in any form (e.g., omalizumab).

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Creighton University — Omaha, Nebraska, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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