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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: ALK Alutard 5-grasses and birch; Drug: ALK Diluent

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

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: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• 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