Clinical trial NCT03682965: Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
Official title: Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis Due to Tree Pollen
Allergic Conjunctivitis
Allergic Rhinoconjunctivitis
Keywords: Mountain Cedar
Juniperus Ashei
Pollinosis
Intra-lymphatic
Lead sponsor: Texan Allergy & Sinus Center
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Average Daily Total Combined Score (TCS)
timeFrame: Up to 4 months
Secondary outcomes:
measure: Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score
timeFrame: Assessed up to 4 months, number of actual peak pollen season days was 27
measure: Patient Reported Pain or Discomfort Following Intra-lymphatic Injections
timeFrame: Immediately after the ILIT procedure
measure: Patient-reported Treatment Satisfaction at the End of Study
timeFrame: Up to 4 months
measure: Percentage Change in Allergen-specific Serum IgE
timeFrame: Assessed prior to the first injection and to 4-8 weeks after the end of the 2018-2019 pollen season
measure: Total Safety Score (TSS) for Active and Placebo Treatment Groups
timeFrame: 8 weeks
measure: Number of Subjects Who: Experienced Anaphylaxis, Were Treated With Epinephrine, or Experienced Any Other Treatment-emergent SAE Within 60 Minutes of Any of Three Planned ILIT Procedures
timeFrame: 8 weeks
Other outcomes:
measure: Total Number of Rescue Inhaler Uses by Patients With Asthma
timeFrame: Up to 4 month
Locations:
city: Austin
country: United States
facility: Texan Allergy & Sinus Center
state: Texas
city: Grapevine
country: United States
facility: Texan Allergy & Sinus Center
state: Texas
city: San Antonio
country: United States
facility: Texan Allergy & Sinus Center
state: Texas
Study officials:
affiliation: Texan Allergy & Sinus Center
name: Christopher Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.