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
  Purpose

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


Condition Intervention Phase
Grass Pollen Allergy
Biological: Allergovit 6-grasses
Other: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 154
Study Start Date: November 2001
Study Completion Date: August 2010
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Allergovit 6-grasses
Subcutaneous injections
Other Name: Specific immunotherapy with an allergoid preparation.
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.
Other: Placebo
Subcutaneous injections
Other Name: Comparator

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263601

Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Annemie Narkus, M.D.
  More Information

Additional Information:
Publications:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00263601     History of Changes
Other Study ID Numbers: Al0101av
Study First Received: December 8, 2005
Last Updated: June 4, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
Allergovit
Grass pollen allergy

Additional relevant MeSH terms:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 26, 2014