A Trial of the ALK Grass Tablet in Subjects With Hayfever

NCT00227279 | Completed Phase 3

• 1 other identifier: GT-08
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergy

Keywords

Grass pollen allergy; Hayfever; Allergen immunotherapy; Specific immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Quality of life

  Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009

Study Arms (2)

1

EXPERIMENTAL

Biological: ALK Grass tablet

2

PLACEBO COMPARATOR

Biological: ALK Grass tablet

Interventions

ALK Grass tablet BIOLOGICAL

Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligibility Criteria: * A history of grass pollen induced rhinoconjunctivitis * Positive skin prick test to grass * Positive specific IgE to grass

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital

Aarhus C, 8000, Denmark

Location

Related Publications (4)

• 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. doi: 10.1016/j.jaci.2006.05.003.

  PMID: 16890769 RESULT

• 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. doi: 10.1111/j.1398-9995.2007.01402.x.

  PMID: 17620075 RESULT

• 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. doi: 10.1111/j.1398-9995.2007.01416.x.

  PMID: 17620076 RESULT

• Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Riis B, Gronager 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. doi: 10.1016/j.jaci.2007.10.039. Epub 2007 Dec 26.

  PMID: 18155284 RESULT

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Study Officials

• Bente Tholstrup, MSc

  ALK-Abello A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: October 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

DK (1)