NCT05037955

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

August 31, 2021

Last Update Submit

March 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rhinoconjunctivitis quality of life

    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").

    February 2021 through June 2021

Study Arms (3)

ILIT from trial NCT00470457

Patients who received ILIT in the original trial in 2005

SCIT from trial NCT00470457

Patients who received SCIT in the original trial in 2005

SCIT outpatient control

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients with past or current hay fever due to grass pollen sensitisation. The patients received immunotherapy (SCIT or ILIT) in the NCT00470457 trials from 2005. A control group of patients received and completed SCIT as standard treatment of their hay fever at the Allergy Unit of the University Hospital Zurich during the last five years.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

February 1, 2021

Primary Completion

July 1, 2021

Study Completion

February 1, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations