drugset / Trial / NCT01438463

PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis

NCT01438463 ↗

Phase 2 Completed 290 enrolled HAL Allergy
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety. For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.

Timeline

Start
2011-09
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject PURETHAL Mites Unknown 6667 unknown Subcutaneous
Subject PURETHAL Mites Unknown 20000 unknown Subcutaneous
Subject PURETHAL Mites Unknown 50000 unknown Subcutaneous
Subject PURETHAL Mites Unknown 100000 unknown Subcutaneous

Indications