Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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preseasonal immunotherapy scheme

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

perennial immunotherapy scheme

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Other Intervention Names

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Allergovit

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No