A Trial of the ALK Grass Tablet in Subjects With Hayfever

Phase 3

Completed

• Conditions: Allergy
• Interventions: Biological: ALK Grass tablet

• Registration Number: NCT00227279
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ALK Grass tablet	-
2	ALK Grass tablet	-

Primary Outcome Measures

Name	Time	Method
Recording of rhinoconjunctivitis symptoms	Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009
Recording of use of rescue medication	Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009

Secondary Outcome Measures

Name	Time	Method
Quality of life	Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009

Trial Locations

Locations (1)

Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital; 🇩🇰 Aarhus C, Denmark