NCT00824447

Long-term Efficacy and Safety Study With Oralgen Grass Pollen

A Randomised, DB, Plcb Controlled, Multicentre, Multinat. Phase II/III FU Study to Assess Longterm Efficacy and Safety of 3 Different Dose Regimens of Oralgen® GrassPollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Artu Biologicals · Industry
• Sex: All
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.

Detailed description

Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma. Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment. Immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. At present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response. Allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	Oralgen	allergen solution sublingually
OTHER	placebo	placebo control

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-08-01
• Completion: 2009-01-01
• First posted: 2009-01-16
• Last updated: 2010-05-05

Locations

39 sites across 7 countries: Bulgaria, Czechia, Germany, Hungary, Lithuania, Netherlands, Slovakia