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

Medical University of Lodz60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

sublingual allergen extractBIOLOGICAL

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

sublingual allergen extractBIOLOGICAL

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

placeboBIOLOGICAL

Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children with seasonal allergic rhinitis, allergic to grass pollens, first diagnosed at least 2 years before inclusion into the study Exclusion Criteria: * Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study * Allergic rhinitis hospitalisation during the 3 months before the first visit. * Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator. * Excluded medications were systemic corticosteroids. * Patients who were receiving immunotherapy were also excluded.

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Lodz, Łódź Voivodeship, Poland

Outcomes

Primary Outcomes

Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)

Visit 2 (6 months after starting the study), visit 3 (9 months after starting the study), visit 4 (12 months after starting the study), visit 5 (18 months after starting the study), visit 6 (21 months after starting the study), visit 7 (24 months after starting the study).

Time frame: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.

Secondary Outcomes

Change of percent of regulatory lymphocytes in the peripheral blood.

Time frame: at baseline and at the end of the second season (22 months interval)

non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.

Time frame: at the end of the first and second season of the study (12 months interval)

Data from ClinicalTrials.gov

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