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

Last updated: April 18, 2016
Sponsor: Stallergenes Greer
Overall Status: Completed

Phase

2/3

Condition

Allergy

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT00367640
VO34.04
  • Ages 18-45
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written consent

  • Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollenseasons.

  • Sensitised to grass pollen (positive SPT and RAST level of at least class 2).

  • Total symptom score of the RRTSS during the previous pollen season greater than orequal to 12.

  • Safety laboratory resuts within the references ranges

Exclusion

Exclusion Criteria:

  • Pregnancy, breast-feeding/lactation

  • Had received desensitisation treatment for grass pollen

  • Treatment by immunotherapy with another allergen within the previous 5 years

  • Usual contraindications of immunotherapy such as serious immunopathologic conditionsor malignancies

  • Treated with beta-blockers or under continuous corticotherapy

Study Design

Total Participants: 628
Study Start date:
November 01, 2004
Estimated Completion Date:
September 30, 2005