Overview

Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Lodz
Medical Universtity of Lodz
Collaborator:
Allergopharma GmbH & Co. KG
Criteria
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.