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Is Intralymphatic Allergen Immunotherapy Effective and Safe?

NCT04210193 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-12-24

No results posted yet for this study

Summary

15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.

Conditions

  • Allergic Rhinitis Due to Grass Pollen

Interventions

DRUG

ALK Alutard 5-grasses

0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection

DRUG

ALK Diluent

0.1 mL of ALK Diluent as an intralymphatic injection

Sponsors & Collaborators

  • Lars Olaf Cardell

    lead OTHER

Principal Investigators

  • Lars Olaf Cardell, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-25
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210193 on ClinicalTrials.gov