Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523478
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Intratonsillar Immunotherapy for Allergic Rhinitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study on the Efficacy and Safety of Intratonsillar Immunotherapy for Allergic Rhinitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITITFAR
Brief Summary:
This is a prospective open-label positive parallel controlled blinded endpoint clinical study designed to compare the safety and efficacy of Intratonsillar Immunotherapy of Standardized Dust Mite Allergen Extracts Novo Helisen-Depot Allergopharma Merck Germany with Subcutaneous Immunotherapy in patients with Dust Mite Allergic Rhinitis
Participants will be evaluated for safety and efficacy throughout the entire three-year period
Participants will be evaluated for safety and efficacy throughout the entire three-year period
Detailed Description:
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 pointday nasal corticosteroid 2 pointsday and oral corticosteroid 3 pointsday 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
SitesFacilities 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 pointday nasal corticosteroid 2 pointsday and oral corticosteroid 3 pointsday 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
SitesFacilities 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
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?:
None