Sublingual Immunotherapy in Children With Allergic Rhinitis

Not Applicable

Completed

• Conditions: Allergic Rhinitis
• Interventions: Biological: Mite, Mite and Bacterial or Placebo

• Registration Number: NCT01506843
• Lead Sponsor: Federal University of Uberlandia

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.

Study Timeline

• Status Verified: 2007-08
• Study Start: 2008-10
• Primary Completion: 2010-10
• Study Completion: 2011-04
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2012-01-09
• Last Update Submitted: 2012-01-09
• Study First Posted: 2012-01-10
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
mite allergen drop	Mite, Mite and Bacterial or Placebo	Children with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo.
mite plus bacterial extracts	Mite, Mite and Bacterial or Placebo	Vaccine constituted with mite and bacterial extracts will be compared to placebo.
Placebo	Mite, Mite and Bacterial or Placebo	Placebo will be constituted by the same solution used to make dilution of the allergen extracts.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Asthma and Rhinitis Control Program; 🇧🇷 Itumbiara, Goias, Brazil