Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Summary

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Timeline

Start

2004-11

Primary completion

2005-09

Completion

2005-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); 500 IR vs Placebo; p = 0.0006; ANCOVA; NCT00367640 ↗

registry analysis (superiority or other test); 300 IR vs Placebo; p = 0.0001; ANCOVA; NCT00367640 ↗

paper Both the 300-index of reactivity (IR) and 500-IR doses significantly reduced mean Rhinoconjunctivitis Total Symptom Score PMID 17935764 ↗

Publications

• Results Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	grass pollen allergen extract	Unknown	100 unknown	Other
Subject	grass pollen allergen extract	Unknown	300 unknown	Other
Subject	grass pollen allergen extract	Unknown	500 unknown	Other

Indications