Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis

Study Overview
=================
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.

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

Conditions
-----------------
Grass Pollen Allergy

Intervention / Treatment
-----------------
* Biological: Allergovit 6-grasses
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allergovit 6-grasses immunotherapy<br>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<br>* Subcutaneous injections<br>* Other names: Specific immunotherapy with an allergoid preparation.;|
| Placebo Comparator: Placebo<br>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<br>* Subcutaneous injections<br>* Other names: Comparator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergovit, Grass pollen allergy