Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00263601
Study type Interventional
Source Allergopharma GmbH & Co. KG
Contact
Status Completed
Phase Phase 3
Start date November 2001
Completion date August 2010

See also
  Status Clinical Trial Phase
Recruiting NCT05560698 - A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment N/A
Completed NCT01830673 - Regulatory T-cells After Subcutaneous Immunotherapy N/A
Completed NCT01445002 - Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy Phase 2
Active, not recruiting NCT04502966 - Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction Phase 2
Completed NCT01538979 - Phase II Study of Grass Pollen Allergy Vaccine BM32 Phase 2
Completed NCT04435678 - Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens N/A
Completed NCT00264459 - Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture Phase 3
Completed NCT01308021 - Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis Phase 2
Completed NCT00773240 - A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Phase 3