Seasonal Allergic Rhinitis
Conditions
Keywords
allergic rhinitis, perennial immunotherapy, preseasonal immunotherapy
Brief summary
Specific immunotherapy, which involves the administration of allergic extracts to patients with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology. According to the latest studies immunotherapy not only reduces symptoms' severity but also may modify the course of allergic disease by reducing the risk of new sensitisations and development of more advanced stages of the disease.It has been hypothesized basing on clinical observation that perennial immunotherapy is more effective and safer in comparison to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.
Interventions
DRUGgrass (80%) and rye (20%) pollens allergoids
comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.
Sponsors
Allergopharma GmbH & Co. KG
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. IgE-mediated seasonal allergic rhinitis with symptoms during the grass and rye pollens season (May, June, July); 2. Symptoms of allergic rhinoconjunctivitis requiring medication during the last season 3. Positive skin prick test to grass and rye pollens only with wheal at least as large as histamine control reaction and diameter \> 5mm; 4. For female patients effective contraception and negative pregnancy test results were necessary.
Exclusion criteria
1. Previous course of immunotherapy with grass and rye pollens extracts or allergens which are unknown during the last 5 years 2. FEV1 \< 80% of predicted 3. Uncontrolled bronchial asthma according to GINA 4. Non-allergic rhinoconjunctivitis 5. Severe acute or chronic diseases, severe inflammatory diseases 6. Autoimmune diseases, immunosuppression, neoplastic diseases 7. Severe psychiatric and psychological disorders including alcohol or drug abuse 8. Contraindication for application of adrenaline; 9. Treatment with beta-blockers 10. Pregnancy or lactation period 11. Females patients seeking to become pregnant 12. Low compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy | up to 3 months | combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season |
| difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 2nd year of immunotherapy | up to 3 months | combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season |
| difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 3rd year of immunotherapy | up to 3 months | combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season |
Secondary
| Measure | Time frame |
|---|---|
| the differences between study groups in mean daily rhinoconjunctivitis symptoms score | up to 3 months/4 years |
| the differences from baseline in combined symptom medication score | up to 3 months/4 years |
| frequency of adverse reactions during immunotherapy | up to 3 years of immunotherapy |
| the differences between study groups in combined symptom medication score | up to 3 months/4 years |
| the differences between study groups in serum level of sIgG4 | up to 3 months/4 years |
| the differences from baseline a in serum level of sIgG4 | the peak of each pollen season (June) during 4 years of study |
| type of adverse reactions | up to 3 years of immunotherapy |
| the differences from baseline in mean daily rhinoconjunctivitis symptoms score | up to 3 months/4 years |
Countries
Poland
Outcome results
None listed