Rhinoconjunctivitis Due to Grass Pollen Allergy Clinical Trial
Official 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
| Verified date | December 2015 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 156 |
| Est. completion date | March 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Clinic for Dermatology University Hospital of Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich | AlleCure |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety efficacy and toxicity | 3 years |