Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study (TX-SMILE)
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|ClinicalTrials.gov Identifier: NCT03682965|
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Due to Tree Pollen Allergic Conjunctivitis Allergic Rhinoconjunctivitis||Biological: Intra-lymphatic allergenic extract Biological: Intra-lymphatic placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study|
|Actual Study Start Date :||September 28, 2018|
|Actual Primary Completion Date :||March 6, 2019|
|Actual Study Completion Date :||April 29, 2019|
Experimental: Intra-lymphatic allergenic extract
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
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.
Other Name: NDC02686614
Placebo Comparator: Intra-lymphatic placebo
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
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.
- Average daily Total Combined Score (TCS) [ Time Frame: Up to 4 months ]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
- Proportion of days in which active patients experience a lower Total Combined Score than placebo patients. [ Time Frame: Up to 4 months ]To evaluate the efficacy of intra-lymphatic immunotherapy relative to placebo during the 2018-2019 Texas Mountain Cedar allergy season based on the proportion of days for which active treatment patients have a lower average total combined score TCS than the placebo patients. 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.
- Patient reported pain or discomfort following intra-lymphatic injections [ Time Frame: Up to 30 minutes post-treatment ]Patient reported pain will be measured immediately after and 30 minutes post ILIT procedure using the Numeric Rating Scale 11 (NRS-11 rating scale). The NRS-11 asks patients to rate their pain on a scale from 0 (no pain or discomfort) to 11 (worst possible pain).
- Patient-reported treatment satisfaction at the end of study [ Time Frame: Up to 4 months ]Patient-reported treatment satisfaction at the end of the study using four Likert-style question, PGI-S and two selected questions modified from the Patient Experience Questionnaire (PEQ), "Are you satisfied with the treatment" and "Would you recommend the treatment to your friends or family?"
- Change in allergen-specific serum IgE [ Time Frame: Up to 4 months ]Average relative change in allergen-specific IgE baseline to the end-of-study visit between active ILIT and placebo.
- Comparison of average total safety score (TSS) for active and placebo treatment groups [ Time Frame: 8 weeks ]The total safety score is a is based on World Allergy Organization grading for allergic reactions. Following allergen or placebo exposure via intra-lymphatic injection, patients are monitored for local and systemic allergic reactions for up to 60 minutes post-procedure. At each exposure, a score is rated on a scale from none = 0, local reactions only = 1, mild systemic reactions (WAO Grade 1/2) = 2, moderate systemic reaction (WAO Grade 3) = 3, and severe systemic reaction (WAO grade 4) = 4. The total safety score is the sum of the patient's score across all three treatments (exposures). Thus, the subject may have a score from 0 to 12 with 0 reflecting no allergic reaction to the allergen and 12 reflecting severe allergic reactions.
- Relative safety of ILIT for Mountain Cedar pollinosis vs placebo (proportion of subjects who: experience anaphylaxis, treated with epinephrine, or experience any other treatment-emergent, (SAE) within 60 minutes of any of three planned ILIT procedures [ Time Frame: 8 weeks ]
To evaluate the safety of ILIT for Mountain Cedar pollinosis relative to placebo control based on the proportion of subjects receiving allergenic extract versus the proportion of subjects receiving placebo that:
- experience anaphylaxis, or
- are treated with epinephrine, or
- experience any other treatment-emergent, serious adverse event (SAE) within 60 minutes of any of the three planned ILIT procedures.
- Use of rescue inhalers by patients with asthma [ Time Frame: Up to 4 month ]Relative use of rescue inhalers by patients with comorbid asthma between active and placebo groups during the 2018-2019 Mountain Cedar pollen season.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682965
|United States, Texas|
|Texan Allergy & Sinus Center|
|Austin, Texas, United States, 78758|
|Texan Allergy & Sinus Center|
|Grapevine, Texas, United States, 76051|
|Texan Allergy & Sinus Center|
|San Antonio, Texas, United States, 78232|
|Principal Investigator:||Christopher Thompson, MD||Texan Allergy & Sinus Center|