NCT00470457CompletedPhase 2
A Randomized Study to Evaluate a Novel Method of Specific Allergen Immunotherapy in Grass and/or Tree Pollen Allergic Subjects by Intralymphatic Allergen Administration
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Safety efficacy and toxicity
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Safety efficacy and toxicity
Time Frame: 3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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