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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
SUBLIVAC® Grasses/Placebo treatment
SUBLIVAC® Grasses treatment
Placebo treatment
Clinical index score (CIS), measured during the pollen season, in the treatment group compared to the placebo group.
Time frame: June, July, August 2007
CIS derived variables
Time frame: June, July and August 2007
RQLQ, quantitative skin prick test
Time frame: Pollen season 2006 and 2007
oral allergy syndrome
Time frame: October 2006 until September 2007
mast-cell serum tryptase
Time frame: 6 months therapy
specific immunoglobulins (IgE and IgG).
Time frame: 6 months therapy
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Dr. P. van Durme
Antwerp, Belgium
Centrum Gespecialiseerde Geneeskunde Genk
Genk, Belgium
UZ Gent, Dienst NKO, 1P1
Ghent, Belgium
UZ Gasthuisberg, Afd. Allergie/Immunologie
Leuven, Belgium
UZ Gasthuisberg, Dienst Kindergeneeskunde
Leuven, Belgium
UZ Gasthuisberg, lokatie St. Rafaël
Leuven, Belgium
Kinderallergie-Astma kinderz.
Mechelen, Belgium
Allergologie Aachen
Aachen, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Studienzentrum Berlin
Berlin, Germany
...and 50 more locations