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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014