A Trial of Grazax in Subjects With Hayfever

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421655
• Other study ID #: GT-14
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2007
• Last updated: June 23, 2015
• Start date: December 2006
• Est. completion date: October 2007

Study information

• Verified date: June 2015
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• Grazax
Tablets 75,000 SQT and matching placebo. One tablet daily.

Locations

Country	Name	City	State
United States	CompleWare Corporation	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of allergy symptoms		Grass pollen season 2007	Yes