NCT02394600

The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This pilot study is a Phase IV, single center, placebo-controlled, parallel study design conducted using the Environmental Exposure Unit (EEU). The study will aim to be determine whether there are any benefits from Grastek® for the treatment of birch-pollen induced allergic rhinoconjunctivitis. Grastek® is a Health Canada and FDA approved sublingual immunotherapy (SLIT) for the treatment of grass-pollen induced allergic rhinoconjunctivitis. The EEU provides a closed environment in which participants are exposed to a predetermined, controlled, constant level of airborne pollen. 96 participants will complete this study and will either receive Grastek® or placebo in a 1:1 ratio. The study will consist of a screening visit, a pre-treatment pollen exposure visit, 60 days of treatment with Grastek® or placebo, two treatment visits and a follow-up pollen exposure visit.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	Grastek®	one tablet daily for four months
DRUG	Placebo	one tablet daily for four months

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2015-03-20
• Last updated: 2018-01-29
• Results posted: 2018-01-29

Locations

1 site across 1 country: Canada