Sublingual Immunotherapy in Children With Allergic Rhinitis

Federal University of Uberlandia122 enrolled

Overview

The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.

Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

122

Conditions

Allergic Rhinitis

Interventions

Mite, Mite and Bacterial or PlaceboBIOLOGICAL

All treatments were given by sublingual route according to schedule of EAACI, with some modification. Patients received up-dosing sublingual drops once a day, reaching in approximately 3 months a monthly maintenance dose of 36 μg of Der p 1 given three times a week in alternate days for mite, mite and bacterial allergen extract, and no Der p 1 and no bacterial components in the placebo group. Doses were delivered by using vials equipped with a metered-dose dropper, and subjects were instructed to hold the solution under the tongue for 2 min and not to eat or drink for 60 min after the dose. Subjects self-administered the treatment at home. Adjustments in the schedule were made on an individual basis according to standard guidelines for specific immunotherapy

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of allergic rhinitis * Positive skin test to Dermatophagoides pteronyssinus total extract * Positive serum levels of specific IgE to D. pteronyssinus extract Exclusion Criteria: * Previous allergen immunotherapy * Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test * Long term use of systemic corticosteroid. * Airway infection 30 days prior to the selection. * Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy. * Users of cigarette smoke * Presence of severe skin lesions

Locations (1)

Asthma and Rhinitis Control Program

Itumbiara, Goiás, Brazil

Outcomes

Primary Outcomes

Change from Baseline in Symptom and Medication Scores at 12 months

For clinical evaluation will be used a questionnaire determining the symptom and medication scores.

Time frame: Baseline and 12 months

Secondary Outcomes

Change from Baseline in Specific Antibody Levels.

Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens.

Time frame: Baseline, 12 months and 18 Months

Data from ClinicalTrials.gov

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