Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Stallergenes Greer

Status and phase: Completed; Phase 3

Conditions: Primary Disease

Treatments: Drug: Placebo; Drug: 300 IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803244

VO60.08

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

Full description

To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:

• The Average Adjusted Symptom Score (AASS).

To document the safety of the treatment.

Enrollment: 381 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female outpatients aged 12 to 65 years (inclusive).
2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
3. Positive SPT
4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

Exclusion criteria

1. Positive SPT to any other seasonal allergens present during the grass pollen season
2. Patients with clinically significant confounding symptoms of allergy to other allergens
3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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381 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

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo