ILIT: Follow-up of Rhinitis Quality of Life

NCT ID: NCT05037955

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-02-01

Brief Summary

Re-evaluation of patients treated with intralymphatic immunotherapy (ILIT) in terms of quality of life and therapeutic efficacy and comparison with subcutaneous immunotherapy (SCIT) 15 years post immunotherapy

Detailed Description

In Switzerland, around 20% of the population suffers from hay fever. The allergy usually begins in childhood and can worsen or improve as the child grows. The quality of life of those affected suffers greatly. Since the allergens are seasonally found in the air, patients cannot really avoid the source of the allergy. On the one hand, allergic rhinitis can be treated pharmacologically. On the other hand allergen-specific immunotherapy (AIT) (=desensitization), can be considered. AIT can greatly reduce the symptoms and restore the patient's quality of life. It is the only treatment method that can offer long-term therapeutic success without the need for regular medication.

Subcutaneous immunotherapy (SCIT) is the traditional method in which the allergen is administered subcutaneously over a period of three to four years with alternating treatment intervals. The chances of success are good, but the drop-out rate is comparatively high due to the long treatment period (at least 3 and up to 5 years). In contrast, intralymphatic immunotherapy (ILIT) requires only three sessions over a period of three to four months. The allergen is administered by ultrasound directly into a lymph node. The results are equally good (compared to SCIT), but the treatment time is much shorter.

In the following project, the quality of life of the people who participated in the first ever ILIT study (ClinicalTrials.gov Identifier: NCT00470457) will be evaluated. The aim is to have a meaningful result on the duration of the therapeutic effect, as judged by the patients themselves.

To develop a meaningful result, a questionnaire was designed for patients to fill out at baseline (prior to pollen season). This shold allow assessmen of how each individual's quality of life has evolved since treatment. The study subjects will also receive a standardised (European) questionnaire. This questionnaire refers to the quality of life and symptoms of the last seven days and is filled out at baseline (prior to season) and in season (Mai-June). The data will be analysed and presented to the scientific and clinical audience as soon as possible.

Conditions

Allergic Rhinitis Due to Grass Pollen

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ILIT from trial NCT00470457

Patients who received ILIT in the original trial in 2005

No interventions assigned to this group

SCIT from trial NCT00470457

Patients who received SCIT in the original trial in 2005

No interventions assigned to this group

SCIT outpatient control

Patients who visited the allergy unit at the University Hospital Zurich and completed SCIT in the last 5 years

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Receiving ILIT or SCIT treatment at the USZ.
• Indication: hay fever (type I sensitisation to grass pollen)
• Adult male and female patients
• Written/digital informed consent of the participating person
• Complete return of both questionnaires

Exclusion Criteria

• Discontinuation of immunotherapy
• Incomplete data set
• Pathological barrier (e.g. dementia)
• Language barrier (not understanding the German language)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Pal Johansen

Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2020-02369

Identifier Type: -

Identifier Source: org_study_id