A Trial of the ALK Grass Tablet in Subjects With Hayfever

Allergy Clinical Trial

Official title:

A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227279
• Other study ID #: GT-08
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2005
• Last updated: January 28, 2013
• Start date: October 2004
• Est. completion date: September 2009

Study information

• Verified date: January 2013
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencySweden: Medical Products AgencyGermany: Paul-Ehrlich-InstitutNetherlands: Medicines Evaluation Board (MEB)Austria: Federal Ministry for Health and WomenItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00146991

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Eligibility Criteria:

• A history of grass pollen induced rhinoconjunctivitis

• Positive skin prick test to grass

• Positive specific IgE to grass

Study Design

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

Related Conditions & MeSH terms

• Allergy

Intervention

Biological:
• ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

Locations

Country	Name	City	State
Denmark	Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Calderon MA, Birk AO, Andersen JS, Durham SR. Prolonged preseasonal treatment phase with Grazax sublingual immunotherapy increases clinical efficacy. Allergy. 2007 Aug;62(8):958-61. — View Citation

Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Riis B, Grønager PM, Durham SR. Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years. J Allergy Clin Immunol. 2008 — View Citation

Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Rivas MF, Ribel M, Durham SR. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006 Aug;118(2):434-40 — View Citation

Durham SR, Riis B. Grass allergen tablet immunotherapy relieves individual seasonal eye and nasal symptoms, including nasal blockage. Allergy. 2007 Aug;62(8):954-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of rhinoconjunctivitis symptoms		Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009	No
Primary	Recording of use of rescue medication		Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009	No
Secondary	Quality of life		Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009	No