Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
Condition: Allergic Rhinitis Due to Tree Pollen; Allergic Conjunctivitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic
Intervention: Intra-lymphatic allergenic extract; Intra-lymphatic placebo
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mountain Cedar; Juniperus Ashei; Pollinosis; Intra-lymphatic

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Both male and female adult patients with a history of Season Allergic Rhinitis (SAR)
             with bothersome symptoms due to Mountain Cedar pollinosis confirmed using the Modified
             Quantitate Test (MQT; defined as a wheal greater than or equal to 3 millimeters larger
             than the diluent control)

          2. Patients must be willing to provide written, informed consent

          3. Patients must be willing and able to comply with study procedures

          4. Women of childbearing potential must agree to use an acceptable form of contraception
             during the trial

        Exclusion Criteria:

          1. Patients less than 18 years of age

          2. Clinically-significant chronic sinusitis, as determined by the investigator

          3. History of anaphylaxis during Mountain Cedar skin prick testing

          4. Participation in another clinical trial or use of an experimental medication within 30
             days of enrollment

          5. Medically significant co-morbidities that, in the opinion of the investigator, place
             the subject at increased risk during the study, including but not limited to:

               1. Autoimmune diseases, other than allergic rhinitis (AR), stable allergic asthma,
                  eczema and food sensitivities

               2. Pulmonary or respiratory diseases other than stable asthma

               3. Cancer other than basal cell carcinoma

               4. Coronary artery disease or hypertension treated with beta-blockers

               5. Clinically significant impairment of renal or hepatic function

          6. Use of concomitant medications that, in the opinion of the investigator, may reduce
             the effectiveness of rescue treatments for anaphylaxis (e.g. beta-blockers) or alter
             the immune response to allergen immunotherapy (e.g., immunosuppressants, systemic
             corticosteroids)

          7. Previously completed immunotherapy for Mountain Cedar pollinosis, that in the opinion
             of the investigator would interfere with the assessment or treatment of the patient

          8. Inability to access suitable lymph nodes for intralympahtic injections

          9. Plans to leave the area for a significant period of the upcoming Mountain Cedar pollen
             season

         10. Pregnant or lactating females