NCT00501527

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.

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 three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).

Conditions

• Rhinitis, Allergic, Seasonal
• Conjunctivitis, Allergic
• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Immunotherapy with modified extract of P. pratense pollen	Sublingual (2 drops daily)
OTHER	Placebo	Placebo 2 drops daily

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-07-16
• Last updated: 2010-12-17

Locations

1 site across 1 country: Spain