Clinical trial NCT04296474: Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass
Official title: Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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* withdrawn informed consent

Primary outcomes:
measure: Nasal grass allergen provocation
timeFrame: 5-6 years after active or placebo ILIT
Secondary outcomes:
measure: Nasal birch allergen provocation
timeFrame: 5-6 years after active or placebo ILIT
measure: Combined symptoms and medciations score
timeFrame: Pollen season 5-7 years after active or placebo ILIT
measure: Rhinoconjunctivitis quality of life questionnaire
timeFrame: Pollen season 5-7 years after active or placebo ILIT
measure: Sinonasal outcome test quality of life questionnaire
timeFrame: Pollen season 5-7 years after active or placebo ILIT
measure: Allergen specific IgE
timeFrame: 5-6 years after active or placebo ILIT
measure: Allergen specific IgG4
timeFrame: 5-6 years after active or placebo ILIT
measure: T-cell and basophil activation
timeFrame: 5-6 years after active or placebo ILIT
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund
city: Malmö
country: Sweden
facility: Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö
city: Stockholm
country: Sweden
facility: ENT department, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Lars Olaf Cardell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hellkvist L, Hjalmarsson E, Kumlien Georen S, Karlsson A, Lundkvist K, Winqvist O, Westin U, Cardell LO. Intralymphatic immunotherapy with 2 concomitant allergens, birch and grass: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2018 Oct;142(4):1338-1341.e9. doi: 10.1016/j.jaci.2018.05.030. Epub 2018 Jun 13. No abstract available.