Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
Twin SUBLIVAC® Grasses Clinical Efficacy Study
To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
Indication under study: IgE mediated allergic disorders triggered by grass pollen.
Number of centres: approximately 50.
Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based
on the outcome the study will be stopped or continued for another season.
Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without
mild asthma (FEV1 > 70%) related to grass pollen, age 12 years or older.
Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily,
until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is reached.
Route of administration: Sublingual application (drops are to be held underneath the tongue
for 2-3 minutes and then will be swallowed).
Duration of treatment: 6 to 12 months blinded per subject . Efficacy parameters
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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