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

December 20, 2011
January 9, 2012
October 2008
October 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01506843 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Sublingual Immunotherapy in Children With Allergic Rhinitis
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinitis
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 allergen drop
    Children with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo.
    Intervention: Biological: Mite, Mite and Bacterial or Placebo
  • Active Comparator: mite plus bacterial extracts
    Vaccine constituted with mite and bacterial extracts will be compared to placebo.
    Intervention: Biological: Mite, Mite and Bacterial or Placebo
  • Placebo Comparator: Placebo
    Placebo will be constituted by the same solution used to make dilution of the allergen extracts.
    Intervention: Biological: Mite, Mite and Bacterial or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
April 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
5 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01506843
F3046, CNPq
Yes
Ernesto Akio Taketomi, Federal University of Uberlandia
Federal University of Uberlandia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigator: Ernesto A Taketomi, MD, PhD Federal University of Uberlandia
Federal University of Uberlandia
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP