Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
A Randomized, Double-blind, Single-center, Placebo Controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults With Seasonal Allergic Rhinitis (ITN043AD)
The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.
This is a randomized, double-blind, single-center, placebo-controlled, three-arm study
comparing SLIT with placebo and SCIT with placebo. The main comparison will be between SLIT
and placebo.
Individuals with severe grass pollen hay fever, with or without associated seasonal asthma,
will be recruited during the pollen season of March through September 2011. Eligible
participants will be randomized to one of the following three treatment arms administered in
a double-blind (masked), double-dummy fashion in a 1:1:1 ratio:
- SLIT + SCIT placebo
- SCIT + SLIT placebo
- SLIT placebo + SCIT placebo
Participants will receive treatment over a 2-year period followed by a 1-year blinded
(masked) withdrawal phase. Participants will be provided with anti-allergic rescue
medications (antihistamine, topical intranasal corticosteroids, and short-acting beta
agonists) throughout the study. Clinical endpoint assessments will be performed at prior to
initiating their assigned treatment, after 1 and 2 years of treatment, and after the 1-year
withdrawal period at 3 years.
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