NCT02849249

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

A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Roxall Medicina España S.A · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinoconjuntivitis

Interventions

Type	Name	Description
BIOLOGICAL	allergovac polimerized (100/100)	Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-07-29
• Last updated: 2017-05-01

Locations

5 sites across 1 country: Spain