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Completed

NCT Number: NCT04296474

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund, Lund, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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  • withdrawn informed consent

Treatment and study plan

ALK Alutard 5-grasses and birch

Drug

Intralymphatic injections

Other names: Grass and birch allergen with aluminum adjuvant

ALK Diluent

Drug

intralymphatic injections

Other names: Human albumin

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Allergen specific IgE

    Time frame: 5-6 years after active or placebo ILIT

    Blood test

  6. Allergen specific IgG4

    Time frame: 5-6 years after active or placebo ILIT

    Blood test

  7. 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

Sponsors and collaborators

Lead sponsor

Lars Olaf Cardell

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2020
Registry last updated
Sep 21, 2022

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

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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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