Allergic Rhinoconjunctivitis Clinical Trial
Official title:
... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo
Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.
Although highly effective, subcutaneous administration of allergens may cause inconvenience
in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated
to find an immunotherapy regimen largely accepted by all groups of patients, including
children.
Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of
immunotherapy. It may be an optimal therapy option especially for children because they
often fear injections.
In this study children are to be treated with a preparation of a grass pollen allergen
extract in a water/glycerol solution with phosphate buffered saline in comparison to a
symptomatic standard treatment with add on placebo, in order to investigate efficacy and
safety of the study drug.
;
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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