NCT00831025

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen

Multicenter, Randomised, Double-blind Placebo-controlled, Subcutaneous Immunotherapy Clinical Trial With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Patients With Hypersensitivity to Olea Pollen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.

Detailed description

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo-controlled study with two arms of treatment: placebo and active.

Conditions

• Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen

Interventions

Type	Name	Description
BIOLOGICAL	Immunotherapy with modified extract of Olea europaea pollen	Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.
BIOLOGICAL	Placebo	Placebo for subcutaneous monthly administration

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-01-28
• Last updated: 2018-02-23

Locations

7 sites across 1 country: Spain