Allergic Rhinitis Due to Grass PollenNCT05037955
ILIT: Follow-up of Rhinitis Quality of Life
An observational study of Allergic Rhinitis Due to Grass Pollen, run by University of Zurich at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollen
- How many people
- 162 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Discontinuation of immunotherapy
- Incomplete data set
- Pathological barrier (e.g. dementia)
- Language barrier (not understanding the German language)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Assessment of Rhinitis - Quality of Life in Allergic Patients Treated With Intralymphatic Immunotherapy (ILIT)
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
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: February 2021 through June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Feb 2021
- Primary completion1 Jul 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to Grass PollenStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pal Johansen, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037955
- Sponsor's protocol ID
- 2020-02369
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Assessment of Rhinitis - Quality of Life in Allergic Patients Treated With Intralymphatic Immunotherapy (ILIT)
- ClinicalTrials.gov ID
- NCT05037955
- Acronym / sponsor ID
- 2020-02369
- Conditions
- Allergic Rhinitis Due to Grass Pollen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Discontinuation of immunotherapy
- Incomplete data set
- Pathological barrier (e.g. dementia)
- Language barrier (not understanding the German language)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis Due to Grass Pollen, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinoconjunctivitis quality of life (time frame: February 2021 through June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.