drugset / Trial / NCT02881879

Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Allergic Rhinoconjunctivitis Sensitized to House Dust Mites

NCT02881879 ↗

Phase 1 Completed 43 enrolled Roxall Medicina España S.A
NaSingle-groupOpen-labelTreatment

Summary

The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy (SCIT) with House Dust Mite (HDM) extract in patients with rhinoconjunctivitis with or without associated mild asthma and sensitized to HDM. In addition,surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity. It will be recruited 50 patients susceptible to receive SCIT with HDM extract along 5 participating spanish sites. Primary endpoint of the study is to assess the safety and tolerability of subcutaneous immunotherapy in depot presentation and quick pattern in patients with rhinoconjunctivitis with or without mild asthma sensitized to house dust mites Secondary objective is to evaluate the indirect immunotherapy efficacy through the measurement of immunoglobulin level changes and cutaneous reactivity

Timeline

Start
2016-07
Primary completion
2017-09
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Allergovac depot DPT/DF (50:50) Vaccine — Subcutaneous

Indications