Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Medical University of Lodz

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01555736

Ne0103AV

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

preseasonal immunotherapy scheme

Active Comparator group

Treatment:

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

perennial immunotherapy scheme

Active Comparator group

Treatment:

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