A Trial of the ALK Grass Tablet in Subjects With Hayfever

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00227279
First received: September 26, 2005
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).


Condition Intervention Phase
Allergy
Biological: ALK Grass tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Recording of rhinoconjunctivitis symptoms [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]
  • Recording of use of rescue medication [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]

Enrollment: 634
Study Start Date: October 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
Placebo Comparator: 2 Biological: ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • A history of grass pollen induced rhinoconjunctivitis
  • Positive skin prick test to grass
  • Positive specific IgE to grass
  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: NCT00227279

Locations
Denmark
Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Bente Tholstrup, MSc ALK-Abello A/S
  More Information

Publications:
Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00227279     History of Changes
Obsolete Identifiers: NCT00146991
Other Study ID Numbers: GT-08
Study First Received: September 26, 2005
Last Updated: January 28, 2013
Health Authority: Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Germany: Paul-Ehrlich-Institut
Netherlands: Medicines Evaluation Board (MEB)
Austria: Federal Ministry for Health and Women
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ALK-Abelló A/S:
Grass pollen allergy
Hayfever
Allergen immunotherapy
Specific immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014