Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children

Allergopharma

Status and phase: Completed; Phase 3

Conditions: Allergic Rhinoconjunctivitis

Treatments: Biological: Grass pollen allergens in a water/glycerol solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841256

2006-005911-82 (EudraCT Number)

AL0506st

Details and patient eligibility

About

Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.

Full description

Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.

Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.

In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.

Enrollment: 207 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 4 - <12 years (at the time of inclusion)
• Positive SPT
• Positive EAST
• Positive CPT

Exclusion criteria

• Serious chronic diseases
• Other perennial allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

207 participants in 2 patient groups, including a placebo group

Immunotherapy

Experimental group

Description:

Grass pollen allergens in a water/glycerol solution

Treatment:

Biological: Grass pollen allergens in a water/glycerol solution

Placebo

Placebo Comparator group

Description:

Water/glycerol solution with phosphate buffered saline

Treatment:

Drug: Placebo