Sublingual Immunotherapy in Children With Allergic Rhinitis (SLIT)

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Ernesto Akio Taketomi, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT01506843
First received: December 20, 2011
Last updated: January 9, 2012
Last verified: August 2007
  Purpose

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.


Condition Intervention
Allergic Rhinitis
Biological: Mite, Mite and Bacterial or Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:
  • Change from Baseline in Symptom and Medication Scores at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    For clinical evaluation will be used a questionnaire determining the symptom and medication scores.


Secondary Outcome Measures:
  • Change from Baseline in Specific Antibody Levels. [ Time Frame: Baseline, 12 months and 18 Months ] [ Designated as safety issue: No ]
    Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens.


Enrollment: 122
Study Start Date: October 2008
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mite allergen drop
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
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
Other Names:
  • mite allergen extract
  • bacterial allergen extract
Active Comparator: mite plus bacterial extracts
Vaccine constituted with mite and bacterial extracts will be compared to placebo.
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
Other Names:
  • mite allergen extract
  • bacterial allergen extract
Placebo Comparator: Placebo
Placebo will be constituted by the same solution used to make dilution of the allergen extracts.
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
Other Names:
  • mite allergen extract
  • bacterial allergen extract

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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506843

Locations
Brazil
Asthma and Rhinitis Control Program
Itumbiara, Goias, Brazil, 75503-520
Sponsors and Collaborators
Federal University of Uberlandia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Ernesto A Taketomi, MD, PhD Federal University of Uberlandia
  More Information

No publications provided

Responsible Party: Ernesto Akio Taketomi, Principal Investigator, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT01506843     History of Changes
Other Study ID Numbers: F3046, CNPq
Study First Received: December 20, 2011
Last Updated: January 9, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Uberlandia:
IgA antibody
IgE antibody
IgG1/IgG4 subclasses
Mite allergy
Sublingual immunotherapy
Saliva

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014