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
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