Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass

September 18, 2022 updated by: Lars Olaf Cardell
52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed.

Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.

Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund
      • Malmö, Sweden, 20502
        • Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö
      • Stockholm, Sweden, 141 86
        • ENT department, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies

Exclusion Criteria:

  • uncontrolled or perennial asthma
  • other pulmonary disease
  • known autoimmune or collagen disease
  • chronic infection
  • other significant disease
  • severe atopic dermatitis
  • use of beta blockers or angiotensin converting enzyme inhibitors as antihypertensive medications
  • symptomatic sensitization to house dust mite or furry animals with daily exposure
  • chronic upper airways disease
  • pregnancy
  • nursing
  • obesity with BMI >30
  • withdrawn informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active ILIT treated
Patients that have received ILIT with birch and grass allergen 5-6 years previously
Drug: ALK Alutard 5-grasses and birch
Intralymphatic injections
Other Names:
  • Grass and birch allergen with aluminum adjuvant
Placebo Comparator: Non- AIT treated
Patients that have received placebo ILIT 5-6 years previously and patients with birch and grass pollen induced allergic rhinitis that have not previously been treated with allergen immunotherapy (AIT).
Drug: ALK Diluent
intralymphatic injections
Other Names:
  • Human albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal grass allergen provocation
Time Frame: 5-6 years after active or placebo ILIT
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
5-6 years after active or placebo ILIT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal birch allergen provocation
Time Frame: 5-6 years after active or placebo ILIT
The symptoms are recorded during 30 minutes after nasal spray with grass allergen
5-6 years after active or placebo ILIT
Combined symptoms and medciations score
Time Frame: Pollen season 5-7 years after active or placebo ILIT
Ranging from 0- no symptoms and medication, to 6- maximum symptoms and medication.
Pollen season 5-7 years after active or placebo ILIT
Rhinoconjunctivitis quality of life questionnaire
Time Frame: Pollen season 5-7 years after active or placebo ILIT
Average score of 28 questions ranging from 0-no impairment of quality of life, to 6- maximum impairment of quality of life.
Pollen season 5-7 years after active or placebo ILIT
Sinonasal outcome test quality of life questionnaire
Time Frame: Pollen season 5-7 years after active or placebo ILIT
Sum of 22 questions. The score ranges from 0-no impairment of quality of life, to 110- maximum impairment of quality of life.
Pollen season 5-7 years after active or placebo ILIT
Allergen specific IgE
Time Frame: 5-6 years after active or placebo ILIT
Blood test
5-6 years after active or placebo ILIT
Allergen specific IgG4
Time Frame: 5-6 years after active or placebo ILIT
Blood test
5-6 years after active or placebo ILIT
T-cell and basophil activation
Time Frame: 5-6 years after active or placebo ILIT
Blood samples and lymph node aspirates are investigated with flow cytometry
5-6 years after active or placebo ILIT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Olaf Cardell

Investigators

  • Principal Investigator: Lars Olaf Cardell, Professor, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Follow-up ILIT 2018/2645-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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