Phase 2
N=21
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
Allergic Rhinitis Due to Tree Pollen · Allergic Conjunctivitis · Allergic Rhinoconjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT03682965 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Average Daily Total Combined Score (TCS) — 10.1; 13.0 units on a scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intra-lymphatic allergenic extract (Biological); Intra-lymphatic placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Christopher Thompson, MD
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Total Combined Score (TCS) |
10.1; 13.0 | 0.004 sig |
| SECONDARY Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score |
20; 7 | <0.05 sig |
| SECONDARY Patient Reported Pain or Discomfort Following Intra-lymphatic Injections |
0.5; 0.5 | — |
| SECONDARY Patient-reported Treatment Satisfaction at the End of Study |
91; 90 | 0.23 |
| SECONDARY Percentage Change in Allergen-specific Serum IgE |
148; 201 | — |
| SECONDARY Total Safety Score (TSS) for Active and Placebo Treatment Groups |
3; 1 | — |
| SECONDARY 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 |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03682965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.