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

Stallergenes Greer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergy

Treatments: Drug: 500 IR grass pollen allergen extract tablet; Drug: 100 IR grass pollen allergen extract tablet; Drug: Placebo tablet; Drug: 300 IR grass pollen allergen extract tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367640

VO34.04

Details and patient eligibility

About

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

Enrollment: 628 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written consent
• Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
• 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 or equal to 12.
• Safety laboratory resuts within the references ranges

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 conditions or malignancies
• Treated with beta-blockers or under continuous corticotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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628 participants in 4 patient groups, including a placebo group

100 IR

Experimental group

Description:

100 IR grass pollen allergen extract tablet

Treatment:

Drug: 100 IR grass pollen allergen extract tablet

300 IR

Experimental group

Description:

300 IR grass pollen allergen extract tablet

Treatment:

Drug: 300 IR grass pollen allergen extract tablet

500 IR

Experimental group

Description:

500 IR grass pollen allergen extract tablet

Treatment:

Drug: 500 IR grass pollen allergen extract tablet

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo tablet