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| Name | Class |
|---|---|
| Allergopharma GmbH & Co. KG | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preseasonal immunotherapy scheme | Active Comparator |
| |
| perennial immunotherapy scheme | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| grass (80%) and rye (20%) pollens allergoids | Drug | comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 1st year of immunotherapy | combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season | up to 3 months |
| difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 2nd year of immunotherapy | combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season | up to 3 months |
| difference between preseasonal and perennial immunotherapy in area under curve of combined symptom medication score during 3rd year of immunotherapy | combined symptom medication score was calculated as a sum of rhinoconjunctivitis symptoms and use of rescue medications during pollen season | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Kuna, MD, PhD | Department of Internal Diseases, Asthma and allergy, Medical University of Lodz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal diseases, Asthma and Allergy | Lodz | 90-153 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23636036 | Derived | 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. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C099681 | allergovit |
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|
| 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 |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |