Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: grass (80%) and rye (20%) pollens allergoids

• Registration Number: NCT01555736
• Lead Sponsor: Medical University of Lodz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2006-07
• Study Completion: 2006-09
• Status Verified: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preseasonal immunotherapy scheme	grass (80%) and rye (20%) pollens allergoids	-
perennial immunotherapy scheme	grass (80%) and rye (20%) pollens allergoids	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
frequency of adverse reactions during immunotherapy	up to 3 years of immunotherapy
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
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
the differences from baseline a in serum level of sIgG4	the peak of each pollen season (June) during 4 years of study
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

Trial Locations

Locations (1)

Department of Internal diseases, Asthma and Allergy; 🇵🇱 Lodz, Poland