A Trial of the ALK Grass Tablet in Subjects With Hayfever

Summary

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

Timeline

Start

2004-10

Primary completion

2009-09

Completion

2009-09

Outcome

Met primary endpoint

paper The primary efficacy analysis showed a reduction of 30% in rhinoconjunctivitis symptom score (P < .0001) PMID 16890769 ↗

paper a reduction of 38% in rhinoconjunctivitis medication score (P < .0001) compared with placebo. PMID 16890769 ↗

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Grazax	Other / unclassified	75000 unknown	Subcutaneous

Indications