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

NCT03682965 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TASC-ILIT-MC-2018
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Mountain Cedar; Juniperus Ashei; Pollinosis; Intra-lymphatic

Outcome Measures

Primary Outcomes (1)

• Average Daily Total Combined Score (TCS)

  The TCS is the preferred endpoint for rhinoconjunctivitis as recommended by the European Academy of Allergy and Clinical Immunology. Scoring of the TCS is from 0 to 38 on each day that it is assessed. The TCS is the sum of the symptom scores for "runny nose", "stuff nose", "sneezing", "itchy nose", "gritty/itchy eyes", and "watery eyes" rated from no symptoms = 0 to severe symptoms = 3 plus the score for use of rescue medications for allergy symptoms 6 points for oral antihistamine, 6 points for eye drops, and 8 points for a nasal corticosteroid. Thus, a lower score represents fewer symptoms and associated need for allergy medication, while a higher score reflects more severe symptoms and the use of medication to treat symptoms. The TCS will be measured during the 2018-2019 Mountain Cedar pollen se

  Up to 4 months

Secondary Outcomes (6)

• Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score

  Assessed up to 4 months, number of actual peak pollen season days was 27

• Patient Reported Pain or Discomfort Following Intra-lymphatic Injections

  Immediately after the ILIT procedure

• Patient-reported Treatment Satisfaction at the End of Study

  Up to 4 months

• Percentage Change in Allergen-specific Serum IgE

  Assessed prior to the first injection and to 4-8 weeks after the end of the 2018-2019 pollen season

• Total Safety Score (TSS) for Active and Placebo Treatment Groups

  8 weeks

Other Outcomes (1)

• Total Number of Rescue Inhaler Uses by Patients With Asthma

  Up to 4 month

Study Arms (2)

Intra-lymphatic allergenic extract

EXPERIMENTAL

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.

Biological: Intra-lymphatic allergenic extract

Intra-lymphatic placebo

PLACEBO COMPARATOR

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.

Biological: Intra-lymphatic placebo

Interventions

Intra-lymphatic allergenic extract BIOLOGICAL

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.

Also known as: NDC02686614

Intra-lymphatic allergenic extract

Intra-lymphatic placebo BIOLOGICAL

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.

Intra-lymphatic placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Patients must be willing to provide written, informed consent
• Patients must be willing and able to comply with study procedures
• Women of childbearing potential must agree to use an acceptable form of contraception during the trial

You may not qualify if:

• Patients less than 18 years of age
• Clinically-significant chronic sinusitis, as determined by the investigator
• History of anaphylaxis during Mountain Cedar skin prick testing
• Participation in another clinical trial or use of an experimental medication within 30 days of enrollment
• 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:
• Autoimmune diseases, other than allergic rhinitis (AR), stable allergic asthma, eczema and food sensitivities
• Pulmonary or respiratory diseases other than stable asthma
• Cancer other than basal cell carcinoma
• Coronary artery disease or hypertension treated with beta-blockers
• Clinically significant impairment of renal or hepatic function
• 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)
• Previously completed immunotherapy for Mountain Cedar pollinosis, that in the opinion of the investigator would interfere with the assessment or treatment of the patient
• Inability to access suitable lymph nodes for intralympahtic injections
• Plans to leave the area for a significant period of the upcoming Mountain Cedar pollen season
• Pregnant or lactating females

Sponsors & Collaborators

• Christopher Thompson, MD: lead

Study Sites (3)

Texan Allergy & Sinus Center

Austin, Texas, 78758, United States

Location

Texan Allergy & Sinus Center

Grapevine, Texas, 76051, United States

Location

Texan Allergy & Sinus Center

San Antonio, Texas, 78232, United States

Location

Related Publications (1)

• 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.

  PMID: 32407947 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Mark Shapiro
• Organization: Pharma Initiatives

mshapiro@pharmainitiatives.com

9193063675

Study Officials

• Christopher Thompson, MD

  Texan Allergy & Sinus Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 25, 2018
• Study Start: September 28, 2018
• Primary Completion: March 6, 2019
• Study Completion: April 29, 2019
• Last Updated: April 20, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)