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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: ALK Alutard 5-grasses and birch
* Drug: ALK Diluent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active ILIT treated<br>Patients that have received ILIT with birch and grass allergen 5-6 years previously | Drug: ALK Alutard 5-grasses and birch<br>* Intralymphatic injections<br>* Other names: Grass and birch allergen with aluminum adjuvant;|
| Placebo Comparator: Non- AIT treated<br>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<br>* intralymphatic injections<br>* Other names: Human albumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal grass allergen provocation | 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 | 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 | 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 | 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 | 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 | Blood test | 5-6 years after active or placebo ILIT | 
| Allergen specific IgG4 | Blood test | 5-6 years after active or placebo ILIT | 
| T-cell and basophil activation | Blood samples and lymph node aspirates are investigated with flow cytometry | 5-6 years after active or placebo ILIT |