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OpenTrials
Completed

NCT Number: NCT00470457

A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy

Allergen specific immunotherapy (SIT) is the only causative treatment of IgE-mediated allergies. The disadvantages of SIT, however, are the requirement of numerous allergen administrations over three to five years, and that the treatment itself causes frequent allergic reactions. We aim at enhancing grass pollen SIT in hay fever patients by injecting the allergen directly into subcutaneous lymph nodes. In a monocentric randomized trial safety and efficacy of intralymphatic immunotherapy (ILIT) with 3 low dose grass pollen extract injections over 2 months are compared to subcutaneous immunotherapy (SCIT) using 54 injections over 3 years.

* Trial with immunodulatory product / biological

Completed

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Key information

Conditions

Rhinoconjunctivitis Due to Grass Pollen Allergy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinic for Dermatology University Hospital of Zurich

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • History of allergic rhino-conjunctivitis in spring and summer
  • Age 18 years to 65 years
  • Positive skin prick test to grass pollen

Exclusion criteria

  • Blood donation within previous 30 days
  • Surgery within the previous 30 days
  • Use of investigational drugs within previous 90 days
  • Pregnancy or nursing
  • Mastocytosis
  • Significant cardiovascular disease
  • Hypertension
  • Active infectious disease
  • Significant hepatic disease
  • Significant renal disease
  • Significant hematological disorder
  • Significant pulmonary disease
  • Moderate or severe asthma
  • Autoimmune disease
  • History of malignancy.
  • Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.

Treatment and study plan

Allergen specific immunotherapy

Biological

Primary outcomes

  1. Safety efficacy and toxicity

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • AlleCure

Registry information

Official study title

A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration

Important dates

Study start
2001
Study completion
2005
First posted
May 7, 2007
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.