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

NCT03682965 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-04-20

Study results available
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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.

Conditions

  • Allergic Rhinitis Due to Tree Pollen
  • Allergic Conjunctivitis
  • Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

Intra-lymphatic allergenic extract

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.

BIOLOGICAL

Intra-lymphatic placebo

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.

Sponsors & Collaborators

  • Christopher Thompson, MD

    lead OTHER

Principal Investigators

  • Christopher Thompson, MD · Texan Allergy & Sinus Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2019-03-06
Completion
2019-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03682965 on ClinicalTrials.gov