Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets

Stallergenes Greer

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Drug: Placebo; Drug: 300 IR (2M); Drug: 300 IR (4M)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418379

VO53.06

Details and patient eligibility

About

A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis

Enrollment: 633 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients aged 18 to 50 years
• Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
• Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
• A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)

Exclusion criteria

• Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
• Asthma requiring treatment other than beta-2 inhaled agonists.
• Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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633 participants in 3 patient groups, including a placebo group

300 IR (4M)

Experimental group

Description:

300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season

Treatment:

Drug: 300 IR (4M)

300 IR (2M)

Experimental group

Description:

300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season

Treatment:

Drug: 300 IR (2M)

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo