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

NCT04296474 | Completed Phase 1

• 1 other identifier: Follow-up ILIT 2018/2645-32
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Nasal birch allergen provocation

  5-6 years after active or placebo ILIT

• Combined symptoms and medciations score

  Pollen season 5-7 years after active or placebo ILIT

• Rhinoconjunctivitis quality of life questionnaire

  Pollen season 5-7 years after active or placebo ILIT

• Sinonasal outcome test quality of life questionnaire

  Pollen season 5-7 years after active or placebo ILIT

• Allergen specific IgE

  5-6 years after active or placebo ILIT

Study Arms (2)

Active ILIT treated

ACTIVE COMPARATOR

Patients that have received ILIT with birch and grass allergen 5-6 years previously

Drug: ALK Alutard 5-grasses and birch

Non- AIT treated

PLACEBO COMPARATOR

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

Interventions

ALK Alutard 5-grasses and birch DRUG

Intralymphatic injections

Also known as: Grass and birch allergen with aluminum adjuvant

Active ILIT treated

ALK Diluent DRUG

intralymphatic injections

Also known as: Human albumin

Non- AIT treated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies

You may not qualify if:

• 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

Sponsors & Collaborators

• Lars Olaf Cardell: lead

Study Sites (3)

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

Lund, 221 85, Sweden

Location

Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö

Malmo, 20502, Sweden

Location

ENT department, Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 29908212 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Lars Olaf Cardell, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: May 15, 2018
• Primary Completion: June 20, 2022
• Study Completion: July 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)