A Trial of the ALK Grass Tablet in Subjects With Hayfever

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ALK-Abelló A/S

ClinicalTrials.gov Identifier:

NCT00227279

First received: September 26, 2005

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Allergy	Biological: ALK Grass tablet	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

U.S. FDA Resources

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:

Recording of rhinoconjunctivitis symptoms [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]
Recording of use of rescue medication [ Time Frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009 ] [ Designated as safety issue: No ]

Enrollment:	634
Study Start Date:	October 2004
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: ALK Grass tablet Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
Placebo Comparator: 2	Biological: ALK Grass tablet Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Eligibility Criteria:

A history of grass pollen induced rhinoconjunctivitis
Positive skin prick test to grass
Positive specific IgE to grass

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227279

Locations

Denmark
Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital
Aarhus C, Denmark, 8000

Sponsors and Collaborators

ALK-Abelló A/S

Investigators

Study Director:

Bente Tholstrup, MSc

ALK-Abello A/S

More Information

Publications:

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.

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.

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.

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 Feb;121(2):512-518.e2. Epub 2007 Dec 26.

Responsible Party:	ALK-Abelló A/S
ClinicalTrials.gov Identifier:	NCT00227279 History of Changes
Obsolete Identifiers:	NCT00146991
Other Study ID Numbers:	GT-08
Study First Received:	September 26, 2005
Last Updated:	January 28, 2013
Health Authority:	Denmark: Danish Medicines Agency Sweden: Medical Products Agency Germany: Paul-Ehrlich-Institut Netherlands: Medicines Evaluation Board (MEB) Austria: Federal Ministry for Health and Women Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ALK-Abelló A/S:

Grass pollen allergy
Hayfever
Allergen immunotherapy
Specific immunotherapy

Additional relevant MeSH terms:

Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases

Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 19, 2013

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