Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults



Status:Terminated
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - 55
Updated:2/17/2019
Start Date:April 2006
End Date:March 2008

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A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults

The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe
and effective in reducing the symptoms of ragweed allergy.

Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy
is a therapeutic option for patients who have allergy symptoms that cannot be adequately
controlled by avoidance of the allergen or medication. It may also be appropriate for those
who cannot tolerate their medications due to side effects or have difficulties with
medication compliance. This study compares the safety and efficacy of two different dosing
regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over
two consecutive ragweed pollen seasons.

Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense
regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.

Inclusion Criteria:

- Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2
consecutive seasons that has required treatment with antihistamines, decongestants
and/or nasal steroids, but where symptom relief has been incomplete

- Is willing to stay in their ragweed area during the historical peak period of the
local ragweed season, and willing to travel for no more than 2 weeks (cumulative time)
outside of their ragweed area during the entire season

Exclusion Criteria:

- Has had any hospital admissions for asthma

- Has smoked within the past year, or has a ≥10-pack per year smoking history

- Has had any previous immunotherapy with ragweed pollen extract, or was in a previous
clinical trial with TOLAMBA™

- Has used Xolair within the past 12 months

- Has a history of anaphylaxis
We found this trial at
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Canton, Ohio 44718
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Cincinnati, Ohio 45231
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Columbia, Missouri 65203
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Dallas, Texas 75231
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Greenfield, Wisconsin 53228
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High Point, North Carolina 27262
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Indianapolis, Indiana 46208
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Milwaukee, Wisconsin 53209
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Minneapolis, Minnesota 55416
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New Braunfels, Texas 78130
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Normal, Illinois 61761
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Oklahoma City, Oklahoma 73120
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Omaha, Nebraska 68130
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2500 California Plaza
Omaha, Nebraska 68102
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Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Oxford, Alabama 36203
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Papillion, Nebraska 68046
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Plymouth, Minnesota 55441
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Saint Louis, Missouri 63141
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San Antonio, Texas
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Skillman, New Jersey 08558
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Stockbridge, Georgia 30281
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Stockbridge, Georgia 30281
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Upland, Pennsylvania 19013
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Warrensburg, Missouri 64093
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