NCT00698594

Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis

Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis Allergic to Grass Pollen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.

Detailed description

Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to the possibility of avoiding injection this therapy allows to have better relationship with patient, and reduce the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.However efficacy and safety of sublingual immunotherapy are still important issues, especially in children. The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	sublingual allergen extract	Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group
BIOLOGICAL	sublingual allergen extract	Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group
BIOLOGICAL	placebo	Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-06-17
• Last updated: 2011-08-22

Locations

1 site across 1 country: Poland