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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2005-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Rhinoconjunctivitis Due to Grass Pollen Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Allergen specific immunotherapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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Clinic for Dermatology University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.

Reference Type DERIVED

PMID: 19001265 (View on PubMed)

Other Identifiers

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ZU-GTP-001

Identifier Type: -

Identifier Source: org_study_id