Clinical trial NCT00263601: Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
Official title: A Multicentre, Placebo Controlled, Double-Blind Study for Evaluation of Safety and Efficacy of Preseasonal Specific Immunotherapy With an Allergoid Preparation of an Extract of a 6 Grass Pollen Mixture in Patients With Clinically Relevant Grass Pollen Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Grass Pollen Allergy
Keywords: Allergovit
Grass pollen allergy
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2005-12-09
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Positive Skin Prick test to grass pollen
* Positive RAST to grass pollen
* Positive specific provocation test to grass pollen

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies

Primary outcomes:
measure: Symptom and Medication Score
timeFrame: Assessment after the first and second grass pollen season.
Secondary outcomes:
measure: Rhinoconjunctivitis Quality-of-Life Questionnaire
timeFrame: First and second grass pollen season
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Annemie Narkus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.