drugset / Trial / NCT01740284

A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine

NCT01740284

Phase 3 Completed 46 enrolled ALK-Abelló A/S
RandomizedCrossoverDouble-blindTreatment

Summary

Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.

Timeline

Start
2008-09
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Desloratadine Small molecule 2.5 mg
Comparator Grazax Other / unclassified 75 unknown Oral

Indications