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Sublingual Immunotherapy in Children With Allergic Rhinitis

NCT01506843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2012-01-10

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis

Interventions

BIOLOGICAL

Mite, 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

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Federal University of Uberlandia

    lead OTHER

Principal Investigators

  • Ernesto A Taketomi, MD, PhD · Federal University of Uberlandia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-10-31
Completion
2011-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01506843 on ClinicalTrials.gov