Sublingual Immunotherapy in Children With Allergic Rhinitis

Clinical Efficacy and Mucosal/Systemic Antibody Response Changes After Sublingual Immunotherapy in Mite-allergic Children in a Randomized Double-blind, Placebo-controlled Study in Brazil

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01506843

Acronym

SLIT

Enrollment

122

Registered

2012-01-10

Start date

2008-10-31

Completion date

2011-04-30

Last updated

2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

IgA antibody, IgE antibody, IgG1/IgG4 subclasses, Mite allergy, Sublingual immunotherapy, Saliva

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALMite, Mite and Bacterial or Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in Symptom and Medication Scores at 12 months	Baseline and 12 months	For clinical evaluation will be used a questionnaire determining the symptom and medication scores.

Secondary

Measure	Time frame	Description
Change from Baseline in Specific Antibody Levels.	Baseline, 12 months and 18 Months	Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026