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Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma (AMETHYST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00671268
First received: April 23, 2008
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation


Condition Intervention Phase
Rhinoconjunctivitis
 Biological: AL0704rP
Biological: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change of Symptom and Medication score [ Time Frame: during the baseline and the following two pollen seasons ] [ Designated as safety issue: No ]

Estimated Enrollment: 498
Study Start Date: March 2008
Estimated Study Completion Date: April 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
strict subcutaneous
 Biological: AL0704rP
strict subcutaneous
Other Name: "na"
Placebo Comparator: 2
strict subcutaneous
 Biological: Placebo
strict subcutaneous
Other Name: "na"

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergic rhinoconjunctivitis attributable to grass pollen
  • Positive SPT
  • Positive EAST
  • Positive provocation test

Exclusion Criteria:

  • serious disease
  • other perennial allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671268

Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Margitta Worm, Professor
  More Information

Additional Information:
Leader in specific allergy research and therapy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00671268     History of Changes
Other Study ID Numbers: AL0704rP, 2007-003208-37
Study First Received: April 23, 2008
Last Updated: March 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013