Allergic Rhinitis Due to Tree PollenPhase 2TX-SMILENCT03682965
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
A Phase 2 study testing Intra-lymphatic allergenic extract in people with Allergic Rhinitis Due to Tree Pollen and Allergic Conjunctivitis, run by Christopher Thompson, MD at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis Due to Tree Pollen, Allergic Conjunctivitis, Allergic Rhinoconjunctivitis
- What is being tested?
- Intra-lymphatic allergenic extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Sep 2018to 29 Apr 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texan Allergy & Sinus Center
Austin, Texas, 78758
Texan Allergy & Sinus Center
Grapevine, Texas, 76051
Texan Allergy & Sinus Center
San Antonio, Texas, 78232
About this study
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.
Read the 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.
- Conditions
- Allergic Rhinitis Due to Tree Pollen, Allergic Conjunctivitis, Allergic Rhinoconjunctivitis
- Being tested
- Intra-lymphatic allergenic extract, Intra-lymphatic placebo
- Keywords
- Mountain Cedar, Juniperus Ashei, Pollinosis, Intra-lymphatic
- Medical subject headings
- Conjunctivitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-lymphatic allergenic extractBiological
Also called NDC02686614
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.
Intra-lymphatic placeboBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Intra-lymphatic placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 4 months
Secondary outcomes (6)
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.
Measured: Assessed up to 4 months, number of actual peak pollen season days was 27
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).
Measured: Immediately after the ILIT procedure
Patient-reported Treatment Satisfaction at the End of Study
Percentage of patients reporting satisfaction with their treatment
Measured: Up to 4 months
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.
Measured: 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
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start28 Sep 2018
- Primary completion6 Mar 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis Due to Tree PollenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Thompson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Thompson, MD, Texan Allergy & Sinus Center
- Investigators
- Christopher Thompson, MD, Principal investigator, Texan Allergy & Sinus Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682965
- Sponsor's protocol ID
- TASC-ILIT-MC-2018
- Acronym
- TX-SMILE
- Status last verified
- Mar 2021
- First submitted
- 12 Sep 2018
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32407947
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
- ClinicalTrials.gov ID
- NCT03682965
- Acronym / sponsor ID
- TX-SMILE / TASC-ILIT-MC-2018
- Conditions
- Allergic Rhinitis Due to Tree Pollen, Allergic Conjunctivitis, Allergic Rhinoconjunctivitis
- Keywords
- Mountain Cedar, Juniperus Ashei, Pollinosis, Intra-lymphatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Christopher Thompson, MDUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-lymphatic allergenic extract | Experimental | Biological: Intra-lymphatic allergenic extractA 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. |
| Intra-lymphatic placebo | Placebo comparator | Biological: Intra-lymphatic placeboDiluent 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-lymphatic allergenic extractAlso: NDC02686614Mountain 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. | Biological | Intra-lymphatic allergenic extract |
| Intra-lymphatic placeboThe 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. | Biological | Intra-lymphatic placebo |
Primary outcome
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
6 secondary outcomes
Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score
Time frame: Assessed up to 4 months, number of actual peak pollen season days was 27
Patient Reported Pain or Discomfort Following Intra-lymphatic Injections
Time frame: Immediately after the ILIT procedure
Patient-reported Treatment Satisfaction at the End of Study
Time frame: Up to 4 months
Percentage Change in Allergen-specific Serum IgE
Time frame: 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
Time frame: 8 weeks
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
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32407947Thompson 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.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis Due to Tree Pollen
Active, not recruitingObservational study
Tyrosine Allergoid Paediatric and Adult Study
Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Thompson, MD principal investigator
Texan Allergy & Sinus Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intra-lymphatic allergenic extract in people with Allergic Rhinitis Due to Tree Pollen and Allergic Conjunctivitis, run by Christopher Thompson, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Total Combined Score (TCS) (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.