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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Medical University of Lodz
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
preseasonal immunotherapy scheme
Intervention: grass (80%) and rye (20%) pollens allergoids (Drug)
perennial immunotherapy scheme
Intervention: grass (80%) and rye (20%) pollens allergoids (Drug)
Outcomes
Primary Outcomes
difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
Investigators
Piotr Kuna, MD, PhD
Professor
Medical University of Lodz