PROVIDERS
Clinical Data
See the evidence—and make Circava System™ Therapy your foundation for allergy relief
The benefit of
nocturnal administration
The immune system profile during the daytime consists of granulocytes, monocytes, and natural killer cells which all peak midday or late in the day. The CD8 and effector cells show low amplitude with peaks in the daytime.
During sleep, The immune system allows for T and B cells to be higher. The CD4+ (helper) and CD8+ (cytotoxic) Naïve cells work more effectively with the Central memory and Lymphocytes. The serum level and invitro production of Interferon gamma, Tumor necrosis factor alpha (TNF alpha) IL-1, IL-2, IL-6, and IL-12 all peak early in the morning.
This pro-inflammatory hormonal boost acts like an adjuvant, presumably on APCs, which slow sleep-dependent products of IL-12, supporting TH1 lineage commitment.
The APCs are central in mediating the sleep-associated peak of T-cells cytokine production; thus, one may conclude that sleep-associated immunological changes produce the ideal immunological context for an increase in efficiency for immunization processing.
Sleep and the circadian system exert a strong regulatory influence on immune functions. Specifically in the lymph node, sleep supports the immunological synapse between the APC and the T-Cells.
During sleep, there is increased production of Pro-inflammatory TH-1 supporting hormones such as melatonin, GH prolactin, and Leptin, whereas anti-inflammatory hormones such as cortisol and catecholamines reach a nadir. This pro-anti-inflammatory hormonal boost during sleep acts as an adjuvant, presumably on APCs that show sleep-dependent production of IL-12, supporting TH1 lineage.
Quality of Life | Clinical Data
Rhinoconjunctivitis quality of life questionnaire mean scores at baseline and post Circava System™ Therapy treatment in 75 adult patients for 1 year
| Base Line | Post Circava Treatment | Statistical Significance | |
|---|---|---|---|
| Mean Activity | 2.84 +/- 1.64 | 1.33 +/- 1.24 | <0.0001 |
| Mean Sleep | 2.24 +/- 1.81 | 1.16 +/- 1.38 | <0.0001 |
| Mean Non-Nose/Eye | 2.67 +/- 1.65 | 1.35 +/- 1.20 | <0.0001 |
| Mean Practical | 2.49 +/- 1.68 | 1.16 +/- 1.05 | <0.0001 |
| Mean Nasal Symptoms | 2.71 +/- 1.57 | 1.45 +/- 1.16 | <0.0001 |
| Mean Eye Symptoms | 2.21 +/- 1.72 | 1.05 +/- 1.26 | <0.0001 |
| Mean Emotional | 2.44 +/- 1.66 | 1.03 +/- 1.23 | <0.0001 |
Rhinoconjunctivitis quality of life questionnaire mean scores at baseline and post Circava System™ Therapy treatment in 20 children
| Base Line | Post Circava System | Statistical Significance | |
|---|---|---|---|
| Mean Activity | 2.83 +/- 1.55 | 0.73 +/- .81 | <0.000 |
| Mean Sleep | 2.20 +/- 1.75 | 0.78 +/- .96 | <0.006 |
| Mean Non-Nose/Eye | 1.98 +/- 1.25 | 0.76 +/- 0.67 | <0.002 |
| Mean Practical | 2.75 +/- 1.69 | 0.75 +/- .73 | <0.000 |
| Mean Nasal Symptoms | 3.01 +/- 1.64 | 0.99 +/- 1.15 | <0.000 |
| Mean Eye Symptoms | 1.86 +/- 1.50 | 0.59 +/- .75 | <0.001 |
| Mean Emotional | 2.00 +/- 1.24 | 0.48 +/- .56 | <0.000 |
SUMMARY
The data in these two charts document the very significant impact of Circava System™ Therapy treatment on restoring the well-being of adult and pediatric populations.
Resolution of Symptoms | Clinical Data
Percent of improvement of individual domains of symptom score after one year of treatment with Circava Global Population (N=66)
P<0.001
Resolution of symptoms in the global population treated with Circava for one year (N=66)
Percent of improvement of individual domains of symptom score after one year of treatment with Circava in patients receiving dosages three times a week (N=15)
P<0.001
84.8%
Percentage of improvement of individual domains of symptom score after one year of maintenance dosage of Circava System™ Therapy 5
SUMMARY
These three graphs document the significant impact of Circava System™ Therapy treatment on individuals that received treatment for one year, indicating an ample effect on symptom resolution5
Average overall symptom score from initial visit to one year5 in children under 4 years of age
Average categorical symptom score in children 3.5-5 years after one year 5
84.6%
Percentage of improvement of individual domains of symptom score in children ages 3.5 to 5 years after one year of maintenance dosage of Circava System™ Therapy 5
SUMMARY
These two graph demonstrates the rapid resolution of individual symptoms after initiating Circava System™ Therapy in a small population of pediatric patients treated for one year.5
Average categorical symptom score resolution in patients receiving maintenance dosages three times per week after one year of treatment
Average overall symptom score from initial visit to one year in patients receiving dosages three times per week
SUMMARY
This data documents the effectiveness of Circava System™ Therapy administration three times per week with adequate resolution of symptoms.5
Total change in total symptom score in the overall population, young children, and patients receiving dosages three times a week
*The overall population and young children received maintenance dosages daily.
Percentage of overall improvement after one year of treatment*
*The overall population and young children received maintenance dosages daily.
SUMMARY
This data documents the effectiveness of Circava System™ Therapy three times per week with a substantial resolution of symptoms.5
Average overall symptom score in young children after one year of treatment
SUMMARY
This data documents the significant impact of Circava System™ Therapy in a pediatric population treated for one year.5
Comparable Efficacy | Clinical Data
Comparative effect of SCIT versus Circava System™ Therapy in symptom resolution and functional parameters in individuals with bronchial asthma
Allergic Rhinitis: Sublingual Immunotherapy vs. Subcutaneous Immunotherapy
SUMMARY
These graphs demonstrate a very comparable effectiveness of Circava System™ Therapy versus allergy shots in symptom resolution.5
Total symptom score changed over 24 weeks of treatment (SCIT vs. Circava System™ Therapy)
SUMMARY
Even though the differences are not statistically significant, the trend suggests the advantage of Circava System™ Therapy over allergy shots.5
Allergic Rhinitis: Subcutaneous Immunotherapy vs Circava System™ Therapy nocturnal administration
SUMMARY
This data indicates a trend favoring Circava System’s™ Therapy bedtime administration versus morning administration in resolving allergy symptoms.5
Patient Compliance | Clinical Data
Total number and percentages of patients that reached maintenance level immunotherapy N=100 Patients
Time to Reach Maintenance | Clinical Data
Time necessary to reach maintenance level of immunotherapy with SCIT or Circava System™ Therapy
SUMMARY
This data indicates superior compliance with the use of Circava System™ Therapy compared with SCIT, as well as a statistically significant shorter period of time to reach maintenance dosage. This demonstrates that Circava System™ Therapy is a more accessible treatment model to the general population.5
Managing Inner City Asthma | Clinical Data
Percent of change in Asthma/Allergy in clinical parameters after 6 months of treatment with Circava System™ Therapy
SUMMARY
In a study conducted in Hillsborough County in Florida, there was an average increase in FEV1 of 21% after six months of Circava System™ Therapy in 24 subjects. There was an average increase in ACT scores of 20% after six months of SLIT in 16 subjects. There was an average decrease in TSS of 28% after six months of Circava System™ Therapy in 36 subjects. 46% of patients had a decrease in asthma medication use after six months of Circava System™ Therapy in 38 subjects.5
Inner city asthma continues to be a problem with no viable solution. Health inequalities are magnified in this population. It results in a significant number of emergency room visits, hospital admissions, and health expenditures. Circava System™ Therapy has the potential to impact this population in a significant manner.
Supporting information and additional data demonstrating the efficacy of Circava System™ Therapy
- Nocturnal Vestibular Immunotherapy with Superior Adherence and Faster Time to Reach Maintenance Compared with SCIT: AllergiGroup data presented to ACAAI in 2023
- Change in Total Symptom Scores in Patients with Amerigroup Coverage Treated with SLIT N=15: Allergi Group data presented to AAAAI in 2012
- Andrea Lucania, ARNP-C and Roberto Garcia, M.D. Managing Inner City Asthma with Nocturnal Immuno Vestibular Oral Therapy: A Retrospective Chart Review. Presented at the 2019 ACAAI Annual Scientific Meeting
- Efficacy of Sublingual Immunotherapy in a Typical American Practice. Presented at the International Food Allergy Symposium (IFAS) Oral Abstract & Poster Sessions. Volume 98, January 2007.
- Theresa A. Grandoff, B.S., Roberto Garcia, M.D. Subcutaneous Immunotherapy Transitioned to Sublingual Immunotherapy during the COVID-19 Pandemic in Asthmatic Allergic Rhinitis and Non-Asthmatic Allergic Rhinitis Patients: A Retrospective Chart Review
Comparative Review Of Subcutaneous Immunotherapy And Nocturnal Vestibular Immunotherapy In Allergic Rhinitis Patients: POSTER # 283 AAAAI 2022 Arizona