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
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: 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 July 23, 2014