NCT01506843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
Last Updated

January 10, 2012

Status Verified

August 1, 2007

Enrollment Period

2 years

First QC Date

December 20, 2011

Last Update Submit

January 9, 2012

Conditions

Allergic Rhinitis

Keywords

IgA antibodyIgE antibodyIgG1/IgG4 subclassesMite allergySublingual immunotherapySaliva

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 12 months

Secondary Outcomes (1)

  • Change from Baseline in Specific Antibody Levels.

    Baseline, 12 months and 18 Months

Study Arms (3)

mite allergen drop

ACTIVE COMPARATOR

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

Biological: Mite, Mite and Bacterial or Placebo

mite plus bacterial extracts

ACTIVE COMPARATOR

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

Biological: Mite, Mite and Bacterial or Placebo

Placebo

PLACEBO COMPARATOR

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

Biological: Mite, Mite and Bacterial or Placebo

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

Also known as: mite allergen extract, bacterial allergen extract
Placebomite allergen dropmite plus bacterial extracts

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of allergic rhinitis
  • Positive skin test to Dermatophagoides pteronyssinus total extract
  • Positive serum levels of specific IgE to D. pteronyssinus extract

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma and Rhinitis Control Program

Itumbiara, Goiás, 75503-520, Brazil

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ernesto A Taketomi, MD, PhD

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2011

First Posted

January 10, 2012

Study Start

October 1, 2008

Primary Completion

October 1, 2010

Study Completion

April 1, 2011

Last Updated

January 10, 2012

Record last verified: 2007-08

Locations

BR(1)