Clinical trial NCT01555736: Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: allergic rhinitis
perennial immunotherapy
preseasonal immunotherapy
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: Allergopharma GmbH & Co. KG
First posted: 2012-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy
timeFrame: up to 3 months
measure: difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 2nd year of immunotherapy
timeFrame: up to 3 months
measure: difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 3rd year of immunotherapy
timeFrame: up to 3 months
Secondary outcomes:
measure: frequency of adverse reactions during immunotherapy
timeFrame: up to 3 years of immunotherapy
measure: type of adverse reactions
timeFrame: up to 3 years of immunotherapy
measure: the differences from baseline in mean daily rhinoconjunctivitis symptoms score
timeFrame: up to 3 months/4 years
measure: the differences between study groups in mean daily rhinoconjunctivitis symptoms score
timeFrame: up to 3 months/4 years
measure: the differences from baseline in combined symptom medication score
timeFrame: up to 3 months/4 years
measure: the differences from baseline a in serum level of sIgG4
timeFrame: the peak of each pollen season (June) during 4 years of study
measure: the differences between study groups in combined symptom medication score
timeFrame: up to 3 months/4 years
measure: the differences between study groups in serum level of sIgG4
timeFrame: up to 3 months/4 years
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Internal diseases, Asthma and Allergy
Study officials:
affiliation: Department of Internal Diseases, Asthma and allergy, Medical University of Lodz
name: Piotr Kuna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tworek D, Bochenska-Marciniak M, Kuprys-Lipinska I, Kupczyk M, Kuna P. Perennial is more effective than preseasonal subcutaneous immunotherapy in the treatment of seasonal allergic rhinoconjunctivitis. Am J Rhinol Allergy. 2013 Jul-Aug;27(4):304-8. doi: 10.2500/ajra.2013.27.3935. Epub 2013 Apr 29.