drugset / Trial / NCT02849249

A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense

NCT02849249 ↗

Phase 1 Completed 52 enrolled Roxall Medicina España S.A
RandomizedParallel-groupOpen-labelTreatment

Summary

The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.

Timeline

Start
2015-09
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Allergovac polimerized Vaccine 0.5 ml Subcutaneous

Indications