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The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo was given the same way as a sublingual preparation. |
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| Liquid formulation of an extract of a 6 grass pollen mixture | Experimental | Sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grass pollen formulation | Biological | Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom and Medication Score (SMS) | The primary endpoint is the change of 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) from the baseline measurement to the measurement after 1.5 years of therapy. | 1.5 years of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Rating Scale | Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS) | 1.5 years |
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Inclusion Criteria:
Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,
Exclusion Criteria:
Serious chronic diseases, Other perennial allergies
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| Name | Affiliation | Role |
|---|---|---|
| Ludger Klimek, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergopharma GmbH & Co. KG | Reinbek | 21465 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17274520 | Result | Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol. 2006 Dec;38(10):355-60. | |
| 18426146 | Result | Pfaar O, Klimek L. Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2008 Mar;100(3):256-63. doi: 10.1016/s1081-1206(10)60451-6. |
| Label | URL |
|---|---|
| Leader in specific allergy research and therapy | View source |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Comparator | Other | Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. |
|
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| D010038 |
| Otorhinolaryngologic Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |