Allergic Rhinitis
Conditions
Brief summary
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
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.
Interventions
DRUGALK Alutard 5-grasses and birch
Intralymphatic injections
DRUGALK Diluent
intralymphatic injections
Sponsors
Lars Olaf Cardell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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30 * withdrawn informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal grass allergen provocation | 5-6 years after active or placebo ILIT | The symptoms are recorded during 30 minutes after nasal spray with grass allergen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined symptoms and medciations score | Pollen season 5-7 years after active or placebo ILIT | Ranging from 0- no symptoms and medication, to 6- maximum symptoms and medication. |
| Rhinoconjunctivitis quality of life questionnaire | 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. |
| Sinonasal outcome test quality of life questionnaire | 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. |
| Nasal birch allergen provocation | 5-6 years after active or placebo ILIT | The symptoms are recorded during 30 minutes after nasal spray with grass allergen |
| Allergen specific IgG4 | 5-6 years after active or placebo ILIT | Blood test |
| T-cell and basophil activation | 5-6 years after active or placebo ILIT | Blood samples and lymph node aspirates are investigated with flow cytometry |
| Allergen specific IgE | 5-6 years after active or placebo ILIT | Blood test |
Countries
Sweden
Outcome results
None listed