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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00263601
First received: December 8, 2005
Last updated: June 4, 2014
Last verified: June 2014

December 8, 2005
June 4, 2014
November 2001
May 2004   (final data collection date for primary outcome measure)
Symptom and Medication Score [ Time Frame: Assessment after the first and second grass pollen season. ] [ Designated as safety issue: No ]
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).
Not Provided
Complete list of historical versions of study NCT00263601 on ClinicalTrials.gov Archive Site
Rhinoconjunctivitis Quality-of-Life Questionnaire [ Time Frame: First and second grass pollen season ] [ Designated as safety issue: No ]
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).
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Grass Pollen Allergy
  • Biological: Allergovit 6-grasses
    Subcutaneous injections
    Other Name: Specific immunotherapy with an allergoid preparation.
  • Other: Placebo
    Subcutaneous injections
    Other Name: Comparator
  • Experimental: Allergovit 6-grasses immunotherapy
    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.
    Intervention: Biological: Allergovit 6-grasses
  • Placebo Comparator: 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.
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
August 2010
May 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00263601
Al0101av
No
Allergopharma GmbH & Co. KG
Allergopharma GmbH & Co. KG
Not Provided
Principal Investigator: Annemie Narkus, M.D.
Allergopharma GmbH & Co. KG
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP