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

NCT02394600 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2018-01-29

Study results available
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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

DRUG

Grastek®

one tablet daily for four months

DRUG

Placebo

one tablet daily for four months

Sponsors & Collaborators

Principal Investigators

  • Anne K Ellis, MD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02394600 on ClinicalTrials.gov