A Phase 3 interventional study of Allergovit 6-grasses and Placebo in Grass Pollen Allergy, sponsored by Allergopharma GmbH & Co. KG. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-05.
Sponsored by Allergopharma GmbH & Co. KG · Phase 3, Interventional, and Treatment
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.
392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.
This study's enrollment of 154 is above the median of 136 across 356 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Allergopharma GmbH & Co. KG is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: Allergovit 6-grasses
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.
Other: Placebo
Subcutaneous injections
Also known as: Specific immunotherapy with an allergoid preparation.
Subcutaneous injections
Also known as: Comparator
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).
Time frame: Assessment after the first and second grass pollen season.
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).
Time frame: First and second grass pollen season
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Allergopharma GmbH & Co. KG