Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study

Phase 2 Completed 21 enrolled Christopher Thompson, MD

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2018-09-28
Primary completion: 2019-03-06
Completion: 2019-04-29

Outcome

Met primary endpoint

registry analysis (superiority test); Intra-lymphatic Allergenic Extract vs Intra-lymphatic Placebo; p = 0.004; Kruskal-Wallis NCT03682965 ↗

Publications

Thompson CP, Silvers S, Shapiro MA. Intralymphatic immunotherapy for mountain cedar pollinosis: A randomized, double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2020 Sep;125(3):311-318.e2. doi: 10.1016/j.anai.2020.04.030. Epub 2020 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mountain Cedar pollen allergenic extract	Unknown	0.1 ml	Other