Ignite Creation Date:
2025-12-18 @ 9:36 AM
Ignite Modification Date:
2025-12-18 @ 9:36 AM
Study NCT ID:
NCT06523478
Status:
None
Last Update Posted:
2024-07-26 00:00:00
First Post:
2024-07-18 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intratonsillar Immunotherapy for Allergic Rhinitis
Sponsor:
None
Organization:
Study Overview
Official Title:
A Study on the Efficacy and Safety of Intratonsillar Immunotherapy for Allergic Rhinitis
Status:
None
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITITFAR
Brief Summary:
Background:
Allergic Rhinitis (AR) presents both nasal and non-nasal symptoms. The global incidence of AR is rising, causing a significant burden. Seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) are the two related clinical divisions of AR. Allergen immunotherapy (AIT) is a treatment involving the injection of specific allergens into the body. Studies have evaluated the effectiveness and safety of subcutaneous (SCIT), sublingual (SLIT), and intra-lymphatic immunotherapy (ILIT). The mechanisms underlying AIT involve both innate and acquired immunity. AIT modulates the activity of various immune cells, including dendritic cells, innate lymphoid cells (ILCs), and regulatory T cells (Tregs).
Intra-lymphatic inoculation (ILIT) has been studied in animals for its ability to improve T cell response to antigens. Studies have found that direct injection of antigens into lymph nodes can lead to improved T cell response and more efficient delivery of the antigen to subcutaneous lymph nodes. ILIT has been effective in treating atopic dermatitis, producing targeted IgG antibodies, enhancing lymphocyte responses, and treating viral and tumor challenges. It has also been effective in treating allergies and reducing symptoms of allergic rhinitis in mice. Studies have found ILIT to be effective in treating atopic dermatitis in dogs caused by common allergens and insect bite hypersensitivity in horses caused by biting midges. In general, animal studies support the use of ILIT as a safe and effective means to induce IgG and T cell responses with fewer treatments and lower doses compared to subcutaneous injection across a range of species.
Objectives:
The primary objective is to explore the efficacy, clinical value, and possible mechanism of action of Intratonsillar Immunotherapy (ITIT) by recording and analyzing the questionnaire scores after ITIT versus SCIT, while comparing the trend of bio-indicator changes in these two treatments.
Primary Endpoint:
Combined Symptom and Medication Score (CSMS): CSMS serves as the primary efficacy endpoint, tracking changes in participant symptoms and assessing the sustainability and stability of treatment effects. It comprises:
Allergen-induced symptom score: Scored from 0 (no symptoms) to 3 (most severe symptoms) for nasal congestion, rhinorrhea, nasal itching, sneezing, eye itching, and tearing, with the average yielding the symptom score (SS).
Emergency medication use related to allergy symptoms: Assigned points based on antihistamine (1 point/day), nasal corticosteroid (2 points/day), and oral corticosteroid (3 points/day) usage, with the highest value determining the medication score (MS).
CSMS (0-6) = SS (0-3) + MS (0-3). Recorded at baseline and 1, 2, 3, 6, 12, 24, and 36 months post-dust mite extract treatment.
Adverse Reactions: Participants were observed for 30 minutes post-injection and encouraged to report any adverse events during follow-up. Adverse reactions were classified as local (LR) or systemic (SR) according to the World Allergy Organization Subcutaneous Immunotherapy Response Classification System. Detailed records included occurrence time, number of injections, clinical manifestations, and management measures.
Study Population:
A total of 120 screened participants will be required to enroll 60 subjects in each group, with an age range of 5-65 years.
Sites/Facilities Enrolling Participants:
Renmin Hospital of Wuhan University will recruit participants.
Description of Study Intervention:
In this study, participants who meet the enrollment criteria will be randomly assigned to two groups. The random assignment will be performed by an independent investigator using a computer-generated sequence of random numbers. The assignment process will be conducted before participants are enrolled to ensure fairness and randomness in the grouping. Each group will be assigned an equal number of participants to ensure the objectivity and comparability of the studies.
Due to the obvious differences between the treatment methods of the experimental group and the control group, it is difficult to blind the subjects, researchers, and evaluators. Therefore, a non-blind experimental design is adopted. To minimize bias, blind data review will be employed.
Allergic Rhinitis (AR) presents both nasal and non-nasal symptoms. The global incidence of AR is rising, causing a significant burden. Seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) are the two related clinical divisions of AR. Allergen immunotherapy (AIT) is a treatment involving the injection of specific allergens into the body. Studies have evaluated the effectiveness and safety of subcutaneous (SCIT), sublingual (SLIT), and intra-lymphatic immunotherapy (ILIT). The mechanisms underlying AIT involve both innate and acquired immunity. AIT modulates the activity of various immune cells, including dendritic cells, innate lymphoid cells (ILCs), and regulatory T cells (Tregs).
Intra-lymphatic inoculation (ILIT) has been studied in animals for its ability to improve T cell response to antigens. Studies have found that direct injection of antigens into lymph nodes can lead to improved T cell response and more efficient delivery of the antigen to subcutaneous lymph nodes. ILIT has been effective in treating atopic dermatitis, producing targeted IgG antibodies, enhancing lymphocyte responses, and treating viral and tumor challenges. It has also been effective in treating allergies and reducing symptoms of allergic rhinitis in mice. Studies have found ILIT to be effective in treating atopic dermatitis in dogs caused by common allergens and insect bite hypersensitivity in horses caused by biting midges. In general, animal studies support the use of ILIT as a safe and effective means to induce IgG and T cell responses with fewer treatments and lower doses compared to subcutaneous injection across a range of species.
Objectives:
The primary objective is to explore the efficacy, clinical value, and possible mechanism of action of Intratonsillar Immunotherapy (ITIT) by recording and analyzing the questionnaire scores after ITIT versus SCIT, while comparing the trend of bio-indicator changes in these two treatments.
Primary Endpoint:
Combined Symptom and Medication Score (CSMS): CSMS serves as the primary efficacy endpoint, tracking changes in participant symptoms and assessing the sustainability and stability of treatment effects. It comprises:
Allergen-induced symptom score: Scored from 0 (no symptoms) to 3 (most severe symptoms) for nasal congestion, rhinorrhea, nasal itching, sneezing, eye itching, and tearing, with the average yielding the symptom score (SS).
Emergency medication use related to allergy symptoms: Assigned points based on antihistamine (1 point/day), nasal corticosteroid (2 points/day), and oral corticosteroid (3 points/day) usage, with the highest value determining the medication score (MS).
CSMS (0-6) = SS (0-3) + MS (0-3). Recorded at baseline and 1, 2, 3, 6, 12, 24, and 36 months post-dust mite extract treatment.
Adverse Reactions: Participants were observed for 30 minutes post-injection and encouraged to report any adverse events during follow-up. Adverse reactions were classified as local (LR) or systemic (SR) according to the World Allergy Organization Subcutaneous Immunotherapy Response Classification System. Detailed records included occurrence time, number of injections, clinical manifestations, and management measures.
Study Population:
A total of 120 screened participants will be required to enroll 60 subjects in each group, with an age range of 5-65 years.
Sites/Facilities Enrolling Participants:
Renmin Hospital of Wuhan University will recruit participants.
Description of Study Intervention:
In this study, participants who meet the enrollment criteria will be randomly assigned to two groups. The random assignment will be performed by an independent investigator using a computer-generated sequence of random numbers. The assignment process will be conducted before participants are enrolled to ensure fairness and randomness in the grouping. Each group will be assigned an equal number of participants to ensure the objectivity and comparability of the studies.
Due to the obvious differences between the treatment methods of the experimental group and the control group, it is difficult to blind the subjects, researchers, and evaluators. Therefore, a non-blind experimental design is adopted. To minimize bias, blind data review will be employed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: