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

Phase 3

Completed

• Conditions: Grass Pollen Allergy
• Interventions: Biological: Allergovit 6-grasses; Other: Placebo

• Registration Number: NCT00263601
• Lead Sponsor: Allergopharma GmbH & Co. KG

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.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2004-05
• Study First Submitted: 2005-12-08
• Study First Submitted QC: 2005-12-08
• Study First Posted: 2005-12-09
• Study Completion: 2010-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allergovit 6-grasses immunotherapy	Allergovit 6-grasses	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Symptom and Medication Score	Assessment after the first and second grass pollen season.	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).

Secondary Outcome Measures

Name	Time	Method
Rhinoconjunctivitis Quality-of-Life Questionnaire	First and second grass pollen season	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).

Trial Locations

Locations (1)

Allergopharma GmbH & Co. KG; 🇩🇪 Reinbek, Germany