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: January 23, 2014
Last verified: January 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: Grass pollen Allergoid
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: During the grass pollen season ] [ Designated as safety issue: No ]
  • Patient documentation in a diary [ Time Frame: During the grass pollen season ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
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: Active
Biological /Vaccine
Biological: Grass pollen Allergoid
Subcutaneous injections
Placebo Comparator: Placebo Biological: Grass pollen Allergoid
Subcutaneous injections

  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
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: January 23, 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 April 16, 2014