NCT00916760

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

Clinical, Multi-centre, Randomised, Double-blind Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerized Extract of Parietaria Judaica Pollen on Patients With Hypersensitivity to This Pollen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (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 the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass 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

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	Depigoid Parietaria judaica 1000DPP/ml	Subcutaneous monthly treatment
BIOLOGICAL	Placebo	Subcutaneous monthly treatment

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-06-10
• Last updated: 2013-11-11

Locations

11 sites across 1 country: Spain