The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
202
CHR Saint Joseph Warquignies
Boussu, Belgium
AZ Sint Lucas
Bruges, Belgium
Clinique du Parc Léopold
Brussels, Belgium
Impact of gpASIT+TM on the clinical efficacy of the subjects
The following parameter will be assessed: rhinoconjunctivitis total symptom score
Time frame: grass pollen season 2011 (April to July)
Clinical tolerability and safety of the treatment
The following parameters will be assessed: general physical status, vital signs, haematological parameters, general blodd biochemistry parameters, all (serious) adverse events, immunological analysis (total IgG, IgE) and inflammatory parameters (CRP, sedimentation rate)
Time frame: 8 months
Impact of gpASIT+TM on the immunological status of the subjects
The following parameter will be assessed: allergen-specific immunoglobulin concentrations
Time frame: screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011)
Impact of gpASIT+TM on the clinical status of the subjects
The average daily symptom and rescue medication scores will be assessed.
Time frame: grass pollen season 2011 (April-July)
Impact of gpASIT+TM on the quality of life of the subjects
The quality of life will be assessed by the use of validated questionnaires.
Time frame: grass pollen season 2011 (April-July)
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