NCT00916422

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

Clinical, Multi-centre,Randomized, Double-blind, Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerised Extract of Phleum Pratense Pollen on Patients With Hypersensitivity to Grass 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 polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense 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 in an up-dosing cluster regimen for 4 weeks.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	Allergen extract (Phleum pratense)	Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
BIOLOGICAL	Placebo	Subcutaneous monthly treatment

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-01-01
• Completion: 2013-10-01
• First posted: 2009-06-09
• Last updated: 2014-01-29

Locations

23 sites across 2 countries: Hungary, Spain