Phase II HDM-SPIRE Safety and Efficacy Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 65
Updated:6/17/2018
Start Date:September 2014
End Date:April 13, 2017

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A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis

The purpose of this study is to compare the treatment effect of three treatment regimens of
HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue
medication usage, Quality of Life and Sleep Quality


Inclusion Criteria:

- Male or female, aged 18-65 years.

- Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.

- Mean TRSS ≥10

- Positive skin prick test to Der p and Der f.

- Dep p and Der f specific IgE ≥0.7 kU/L

Exclusion Criteria:

- Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3
(www.ginasthma.org)or higher treatment

- FEV1 <80% of predicted.

- Clinically significant confounding symptoms of allergy to seasonal allergens during
the final evaluation period.

- Significant symptoms of another clinically relevant illness that is likely to affect
scoring of rhinoconjunctivitis symptoms.

- Clinically relevant abnormalities detected on physical examination.

- History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
We found this trial at
57
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139
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Vancouver, WA
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Asheville, NC
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Bangor, ME
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Bellevue, NE
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Bethesda, MD
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Birmingham, AL
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Blue Bell, PA
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Brockton, MA
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Canton, OH
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1967
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Cincinnati, OH
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Dallas, TX
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Evansville, IN
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Gaithersburg, MD
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Greenfield, WI
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Hamilton,
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Henrico, VA
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2291
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High Point, NC
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Huntington Beach, California 92646
991
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Huntington Beach, CA
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1557
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Iowa City, IA
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1729
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Kerrville, TX
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Long Beach, CA
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Madison, WI
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366
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Medford, OR
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Milwaukee, WI
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Minneapolis, MN
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Mission Viejo, California 92691
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Mission Viejo, CA
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Napa, CA
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Normal, IL
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Ocean City, NJ
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Orange, CA
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Owensboro, KY
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Pittsburgh, PA
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Plano, TX
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Plymouth, MN
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147
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Portland, OR
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Providence, RI
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Redwood City, CA
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Rochester, NY
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Rockville Centre, New York 11570
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Rockville Centre, NY
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Rolling Hills Estates, California 90274
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Rolling Hills Estates, CA
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617
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Roseville, CA
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Saint Louis, MO
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San Diego, CA
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2
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Shiloh, IL
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South Burlington, Vermont 05403
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Tulsa, OK
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Verona, NJ
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Walnut Creek, CA
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Waterbury, CT
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