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 |
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
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
sites
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