A Trial of Grazax in Subjects With Hayfever

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00421655
First received: January 11, 2007
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.


Condition Intervention Phase
Allergy
Drug: Grazax
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Trial Assessing the Efficacy and Safety of Grazax in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Recording of allergy symptoms [ Time Frame: Grass pollen season 2007 ] [ Designated as safety issue: Yes ]

Enrollment: 329
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Grazax
Tablets 75,000 SQT and matching placebo. One tablet daily.
Placebo Comparator: 2 Drug: Grazax
Tablets 75,000 SQT and matching placebo. One tablet daily.

  Eligibility

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

Inclusion Criteria:

  • History of grass pollen allergy
  • Positive skin prick test to grass
  • Positive specific IgE to grass

Exclusion Criteria

  • FEV1 <70% of predicted value
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421655

Locations
United States, Iowa
CompleWare Corporation
Iowa City, Iowa, United States, 52244-3090
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Kim Simonsen, MD ALK-Abelló A/S
  More Information

No publications provided

Responsible Party: Kim Simonsen, MD, Senior Director, ALK-Abello
ClinicalTrials.gov Identifier: NCT00421655     History of Changes
Other Study ID Numbers: GT-14
Study First Received: January 11, 2007
Last Updated: February 28, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014