Sublingual Immunotherapy in Children With Allergic Rhinitis (SLIT)

Federal University of Uberlandia

Status: Completed

Conditions: Allergic Rhinitis

Treatments: Biological: Mite, Mite and Bacterial or Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01506843

CNPq (Other Grant/Funding Number)

F3046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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122 participants in 3 patient groups, including a placebo group

mite allergen drop

Active Comparator group

Description:

Children with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo.

Treatment:

Biological: Mite, Mite and Bacterial or Placebo

mite plus bacterial extracts

Active Comparator group

Description:

Vaccine constituted with mite and bacterial extracts will be compared to placebo.

Treatment:

Biological: Mite, Mite and Bacterial or Placebo

Placebo

Placebo Comparator group

Description:

Placebo will be constituted by the same solution used to make dilution of the allergen extracts.

Treatment:

Biological: Mite, Mite and Bacterial or Placebo