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The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis
Pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 Daltons by diafiltration. Clinical studies have shown a good tolerance of aqueous grass, ragweed and tree pollen allergoids in comparison with allergen preparations. Adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy. Depot pollen-allergoids were introduced into the German market in 1987 under the trade name Allergovit® and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis. Allergovit® is currently available in many European and non-European countries. A placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time, as pollen seasons of different years are not comparable. Due to the different mechanisms of action, specific immunotherapy can not be compared with anti-allergic drugs. Thus the only chance to prove efficacy for specific immunotherapy (SIT) is to test versus a parallel placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergovit 6-grasses immunotherapy | Experimental | Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season. |
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| Placebo | Placebo Comparator | Placebo injections was given the same way: Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergovit 6-grasses | Biological | Subcutaneous injections |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptom and Medication Score | The area under the curve (AUC) , derived from an analysis period of 42 days of the daily sum of the symptom and medication score (SMS). | Assessment after the first and second grass pollen season. |
| Measure | Description | Time Frame |
|---|---|---|
| Rhinoconjunctivitis Quality-of-Life Questionnaire | Changes in the scores of Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ by E Juniper) at baseline (outside the grass pollen season), every two weeks during the 3 months grass pollen season (year 1+2). | First and second grass pollen season |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annemie Narkus, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergopharma GmbH & Co. KG | Reinbek | 21465 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15876311 | Result | Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A; Study Group. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005 Jun;60(6):801-7. doi: 10.1111/j.1398-9995.2005.00790.x. | |
| 17523386 | Result | Williams A, Henzgen M, Rajakulasingam K. Additional benefit of a third year of specific grass pollen allergoid immunotherapy in patients with seasonal allergic rhinitis. Eur Ann Allergy Clin Immunol. 2007 Apr;39(4):123-6. |
| Label | URL |
|---|---|
| Leader in specific allergy research and therapy | View source |
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| Placebo | Other | Subcutaneous injections |
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