Allergic Rhinitis Clinical Trial
Official title:
A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses
will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks)
compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).
The primary parameter will be the proportion of patients who experience systemic reactions >
grade I within 24 hours after injection or who need more than 2 additional injections during
the up-dosing phase until the maintenance dose has been reached.
It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as
using the conventional regimen.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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