Allergic rhino-conjunctivitis hayfever
Conditions
Interventions
allergen provocation tests
blood sampels
nasal biopsy
intranodal groin injection
Sponsors
HagaZiekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Sensibilisation to grass pollen age between 18 and 50 years old Informed consent
Exclusion criteria
Exclusion criteria: No informed consent instable or steroidtherapy dependent atopic astma rhinosinusitis nasal polyps vasomotore rhinitis immunosupressive medication immuondeficiancy (IgG-IgA deficiaccy, HIV-AIDS) pregnany or nursing participation in other medical study history of desensibilisation therapy Significant cardiovascular disease Severe impaired renal function Hypersensitivity to aluminiumhydroxid Childeren untill age of 18 Blood donation within previous 30 days Surgery within the previous 30 days Use of investigational drugs within previous 90 days Mastocytosis 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study outcome measure will be the level of allergic symptoms (VAS score) following intra nasal grass pollen provocation in patients treated with Alutard grass pollen compared with the results for patients treated with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in allergic skin prick test reactivity pre and post immunisation between the groups changes in serologic allergy tests pre and post immunisation between the groups changes in serum IgE and Ig4 levels pre and post immunisation between the groups changes in cellular infiltrates in the nasal mucosa pre and post immunisation between the groups | — |
Countries
Netherlands
Outcome results
None listed