At a glance
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Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
In Brief
A Phase 2 clinical trial evaluating Intra-lymphatic allergenic extract and Intra-lymphatic placebo for Allergic Rhinitis Due to Tree Pollen and 2 related conditions. Completed, enrolled 21 participants across 3 sites.
Detailed Summary
TX-SMILE is an investigator-initiated, multi-center, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intra-lymphatic administration of an approved allergenic extract for the immunotherapy treatment of allergic rhinitis and conjunctivitis due to pollen from the conifer Mountain Cedar.
Study Details
Timeline
Interventions
Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.
The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.