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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intra-lymphatic allergenic extract
Intra-lymphatic placebo
Sponsored by
Christopher Thompson, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Tree Pollen focused on measuring Mountain Cedar, Juniperus Ashei, Pollinosis, Intra-lymphatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Texan Allergy & Sinus Center
  • Texan Allergy & Sinus Center
  • Texan Allergy & Sinus Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intra-lymphatic allergenic extract

Intra-lymphatic placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score
Evaluated during the 2018-2019 Texas Mountain Cedar allergy season. The number of days with a lower group average Total Combined Score, comparatively, in each Arm/Group are reported. 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
Patient reported pain will be measured immediately after 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
Percentage of patients reporting satisfaction with their treatment
Percentage Change in Allergen-specific Serum IgE
Percentage change in allergen-specific serum IgE from baseline to the end-of-study visit between active ILIT and placebo.
Total Safety Score (TSS) for Active and Placebo Treatment Groups
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 for each group is the sum of the individual scores of each patient 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, and the TSS for a group is the sum for all patients in the group. The TSS is used to elicit and grade adverse events of interest rather than for statistical analysis.
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
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.

Full Information

First Posted
September 12, 2018
Last Updated
March 29, 2021
Sponsor
Christopher Thompson, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03682965
Brief Title
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
Acronym
TX-SMILE
Official Title
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
April 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Thompson, MD

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis Due to Tree Pollen, Allergic Conjunctivitis, Allergic Rhinoconjunctivitis
Keywords
Mountain Cedar, Juniperus Ashei, Pollinosis, Intra-lymphatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-lymphatic allergenic extract
Arm Type
Experimental
Arm 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.
Arm Title
Intra-lymphatic placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Intra-lymphatic allergenic extract
Other Intervention Name(s)
NDC02686614
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Intra-lymphatic placebo
Intervention Description
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 Measure Information:
Title
Average Daily Total Combined Score (TCS)
Description
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
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score
Description
Evaluated during the 2018-2019 Texas Mountain Cedar allergy season. The number of days with a lower group average Total Combined Score, comparatively, in each Arm/Group are reported. 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.
Time Frame
Assessed up to 4 months, number of actual peak pollen season days was 27
Title
Patient Reported Pain or Discomfort Following Intra-lymphatic Injections
Description
Patient reported pain will be measured immediately after 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).
Time Frame
Immediately after the ILIT procedure
Title
Patient-reported Treatment Satisfaction at the End of Study
Description
Percentage of patients reporting satisfaction with their treatment
Time Frame
Up to 4 months
Title
Percentage Change in Allergen-specific Serum IgE
Description
Percentage change in allergen-specific serum IgE from baseline to the end-of-study visit between active ILIT and placebo.
Time Frame
Assessed prior to the first injection and to 4-8 weeks after the end of the 2018-2019 pollen season
Title
Total Safety Score (TSS) for Active and Placebo Treatment Groups
Description
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 for each group is the sum of the individual scores of each patient 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, and the TSS for a group is the sum for all patients in the group. The TSS is used to elicit and grade adverse events of interest rather than for statistical analysis.
Time Frame
8 weeks
Title
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
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Total Number of Rescue Inhaler Uses by Patients With Asthma
Description
Relative use of rescue inhalers by patients with comorbid asthma between active and placebo groups during the 2018-2019 Mountain Cedar pollen season.
Time Frame
Up to 4 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Thompson, MD
Organizational Affiliation
Texan Allergy & Sinus Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texan Allergy & Sinus Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Texan Allergy & Sinus Center
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Texan Allergy & Sinus Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32407947
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.
Results Reference
derived

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

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