Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05037955 |
| Other study ID # |
2020-02369 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
