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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682965
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Thompson, MD, Texan Allergy & Sinus Center

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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?"

  4. 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.

  5. 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.

  6. 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:

    1. experience anaphylaxis, or
    2. are treated with epinephrine, or
    3. experience any other treatment-emergent, serious adverse event (SAE) within 60 minutes of any of the three planned ILIT procedures.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Christopher Thompson, MD
Investigators
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Principal Investigator: Christopher Thompson, MD Texan Allergy & Sinus Center

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Responsible Party: Christopher Thompson, MD, Principal Investigator, Texan Allergy & Sinus Center
ClinicalTrials.gov Identifier: NCT03682965    
Other Study ID Numbers: TASC-ILIT-MC-2018
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christopher Thompson, MD, Texan Allergy & Sinus Center:
Mountain Cedar
Juniperus Ashei
Pollinosis
Intra-lymphatic
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Conjunctivitis
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Hypersensitivity
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Conjunctival Diseases
Eye Diseases