This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.
Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
374
19.000 BU daily
placebo control
Difference between active and placebo-group based on combined RTSS and RMS score
Time frame: third season
Difference between active and placebo based on RTSS score
Time frame: third season
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AZ St Jan, Campus Sint-Jan
Bruges, Belgium
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Leuven, Belgium
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