NCT00619827

Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

A Randomised, Double-blind, in Parallel Groups Placebo-controlled, Mono-centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

Detailed description

The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	300 IR grass pollen allergen extract tablet	300 IR grass pollen allergen extract tablet once daily during four months
DRUG	Placebo tablet	Placebo tablet once daily during four months

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-02-21
• Last updated: 2016-05-23
• Results posted: 2016-05-23

Locations

1 site across 1 country: Austria