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A Trial of Grazax in Subjects With Hayfever

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ClinicalTrials.gov Identifier: NCT00421655
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : June 24, 2015
Sponsor:
Information provided by:
ALK-Abelló A/S

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

Condition or disease Intervention/treatment Phase
Allergy Drug: Grazax Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : December 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Recording of allergy symptoms [ Time Frame: Grass pollen season 2007 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim Simonsen, MD, Senior Director, ALK-Abello
ClinicalTrials.gov Identifier: NCT00421655     History of Changes
Other Study ID Numbers: GT-14
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015