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Documentation of Efficacy of Intralymphatic Allergen Immunotherapy (ILITNU)

Primary Purpose

Allergic Rhinitis Due to Grass Pollen, Allergic Conjunctivitis of Both Eyes, Allergic Asthma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Grass pollen extract - Alutard Phleum pratense, ALK
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis Due to Grass Pollen focused on measuring Allergen immunotherapy, Allergic rhinoconjunctivitis, grass pollen allergy, intralymphatic immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate-severe grass pollen allergic rhinoconjunctivitis
  • positive skin prick test for grass pollen extract

Exclusion Criteria:

  • significant mugwort allergy
  • previous AIT for grass pollen allergy
  • uncontrolled non-allergic upper airways disease
  • uncontrolled asthma
  • planned depot steroid injections during season
  • uncontrolled autoimmune diseases
  • active malignancies
  • uncontrolled other severe condition, including psychiatric diseases

Sites / Locations

  • Aarhus University Hospital
  • Lars University Ahlbeck

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

grass pollen extract treatment

Placebo

Arm Description

participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract

Participants receive 3 injections with saline (NaCl 0.9%)

Outcomes

Primary Outcome Measures

Combined symptom and medication score, cSMS
daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo. cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use. This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication

Secondary Outcome Measures

side-effects
occurence of side-effects as compared to placebo
correlation of CSMS to pollen count
correlate cSMS to daily pollen counts
combined symptom and medication score, cSMS
change in the combined symptom and medication score from baseline
Rhinitis related quality of life, RQLQ
changes on rhinitis related quality of life
Airwave oscillometry system(AOS), asthma
Influence of ILIT on resistance in the lower airways measured by AOS

Full Information

First Posted
December 27, 2021
Last Updated
January 12, 2022
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT05191186
Brief Title
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy
Acronym
ILITNU
Official Title
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus, University Hospital, Linkoeping

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo
Detailed Description
A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects. Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo. Injections are giving ultrasound-guided with at least 4 weeks intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis Due to Grass Pollen, Allergic Conjunctivitis of Both Eyes, Allergic Asthma
Keywords
Allergen immunotherapy, Allergic rhinoconjunctivitis, grass pollen allergy, intralymphatic immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
parallel group, double blind placebo controlled multi site
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study is run in a double-blind design
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
grass pollen extract treatment
Arm Type
Active Comparator
Arm Description
participants receive 3 injections with Alutard phleum pratense, ALK, grass pollen extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive 3 injections with saline (NaCl 0.9%)
Intervention Type
Drug
Intervention Name(s)
Grass pollen extract - Alutard Phleum pratense, ALK
Other Intervention Name(s)
immunotherapy
Intervention Description
injection in lymph node
Primary Outcome Measure Information:
Title
Combined symptom and medication score, cSMS
Description
daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo. cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use. This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication
Time Frame
2 years
Secondary Outcome Measure Information:
Title
side-effects
Description
occurence of side-effects as compared to placebo
Time Frame
3 months
Title
correlation of CSMS to pollen count
Description
correlate cSMS to daily pollen counts
Time Frame
2 years
Title
combined symptom and medication score, cSMS
Description
change in the combined symptom and medication score from baseline
Time Frame
2 years
Title
Rhinitis related quality of life, RQLQ
Description
changes on rhinitis related quality of life
Time Frame
2 years
Title
Airwave oscillometry system(AOS), asthma
Description
Influence of ILIT on resistance in the lower airways measured by AOS
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate-severe grass pollen allergic rhinoconjunctivitis positive skin prick test for grass pollen extract Exclusion Criteria: significant mugwort allergy previous AIT for grass pollen allergy uncontrolled non-allergic upper airways disease uncontrolled asthma planned depot steroid injections during season uncontrolled autoimmune diseases active malignancies uncontrolled other severe condition, including psychiatric diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes M Schmid, MD PhD
Organizational Affiliation
Aarhus University Hospital/Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Central Region
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Lars University Ahlbeck
City
Linkoeping
State/Province
Oestergotland
ZIP/Postal Code
58183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will publish data
Links:
URL
http://ILIT.NU
Description
project homepage

Learn more about this trial

Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

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