Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

Stallergenes Greer

Status and phase: Completed; Phase 3

Conditions: Allergy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409409

VO52.06

Details and patient eligibility

About

A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Enrollment: 278 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients aged 5 to 17 years.
• Written consent / assent.
• Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
• Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
• Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion criteria

• Patients who have received any desensitisation treatment for grass pollen.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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278 participants in 2 patient groups, including a placebo group

300 IR

Experimental group

Description:

300 IR grass pollen allergen extract tablet

Treatment:

Drug: 300 IR grass pollen allergen extract tablet

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo tablet