Trial | NCT01555736  Report issue

Title

Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy
A Randomised Double-blind Clinical Trial for Evaluation of Efficacy and Safety of Perennial in Comparison to Preseasonal Grass/Rye Pollen Immunotherapy in Patients Suffering From Seasonal Allergic Rhinitis

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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.
Study Started
Jan 31
2003
Primary Completion
Jul 31
2006
Study Completion
Sep 30
2006
Last Update
Mar 21
2012
Estimate

Drug grass (80%) and rye (20%) pollens allergoids

comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.

  • Other names: Allergovit

preseasonal immunotherapy scheme Active Comparator

perennial immunotherapy scheme Active Comparator

Criteria 

Inclusion Criteria:

IgE-mediated seasonal allergic rhinitis with symptoms during the grass and rye pollens season (May, June, July);
Symptoms of allergic rhinoconjunctivitis requiring medication during the last season
Positive skin prick test to grass and rye pollens only with wheal at least as large as histamine control reaction and diameter > 5mm;
For female patients effective contraception and negative pregnancy test results were necessary.

Exclusion Criteria:

Previous course of immunotherapy with grass and rye pollens extracts or allergens which are unknown during the last 5 years
FEV1 < 80% of predicted
Uncontrolled bronchial asthma according to GINA
Non-allergic rhinoconjunctivitis
Severe acute or chronic diseases, severe inflammatory diseases
Autoimmune diseases, immunosuppression, neoplastic diseases
Severe psychiatric and psychological disorders including alcohol or drug abuse
Contraindication for application of adrenaline;
Treatment with beta-blockers
Pregnancy or lactation period
Females patients seeking to become pregnant
Low compliance.
No Results Posted