Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study (TX-SMILE)

Christopher Thompson, MD

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis; Allergic Rhinitis Due to Tree Pollen; Allergic Rhinoconjunctivitis

Treatments: Biological: Intra-lymphatic placebo; Biological: Intra-lymphatic allergenic extract

Study type: Interventional

Funder types: Other

Identifiers

NCT03682965

TASC-ILIT-MC-2018

Details and patient eligibility

About

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.

Full description

TX-SMILE is an investigator-initiated, multi-center, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of an alternative injection site and associated adjustments to dosing and treatment regimen for allergen immunotherapy with a commercially-available, FDA-approved allergenic extract for the immunotherapy treatment of allergic rhinitis and conjunctivitis due to pollen from the conifer Mountain Cedar (Juniperus ashei).

The purpose of this study is to evaluate the effect of a three-dose treatment series of ultrasonography-guided, intra-lymphatic immunotherapy injections over a two-month period prior to the start of the 2018-2019 Mountain Cedar allergy season in central Texas. Patients will be evaluated for safety and tolerability during the treatment period and for efficacy during the 2018-2019 Texas Mountain Cedar pollen season.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

21 participants in 2 patient groups, including a placebo group

Intra-lymphatic allergenic extract

Experimental group

Description:

A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.

Treatment:

Biological: Intra-lymphatic allergenic extract

Intra-lymphatic placebo

Placebo Comparator group

Description:

Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle.

Treatment:

Biological: Intra-lymphatic placebo