The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage
Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about 10 to 20% of the general population. House dust mite allergens are known to cause perennial allergic rhinitis. In designing the present study, the guidelines proposed by the World Allergy Organization (WAO) task force for methodology of immunotherapy studies have been taken into consideration. After a 2-month screening period, patients will be administered the dose of 300 IR- or 500 IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The carry-over effect will be evaluated after a treatment-free follow up period of 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
509
One sublingual tablet daily for one year
One sublingual tablet daily for one year
One sublingual tablet daily for one year
Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period
The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe). It ranges from 0 to 12, the higher the score the more severe the rhinitis.
Time frame: Last 3 months of Year 1
Average Rhinitis Total Symptom Score (ARTSS)
The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.
Time frame: Last 3 months of Year 1
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