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Completed

NCT Number: NCT05037955

ILIT: Follow-up of Rhinitis Quality of Life

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Rhinoconjunctivitis quality of life

    Time frame: February 2021 through June 2021

    The standardised scoring of the outcomes "activities", "sleep", "non-nose/eye symptoms", "practical problems", "nasal symptoms", "eye symptoms", and "emotional" are entered in the form names "Rhinoconjunctivitis quality of life questionnaire with standardised activities (RQLQ)". The scoring is from 0 ("not troubled" or "none of the time") to 6 ("extremely troubled" or "all of the time").

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Follow-up Assessment of Rhinitis - Quality of Life in Allergic Patients Treated With Intralymphatic Immunotherapy (ILIT)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 8, 2021
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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