Sublingual Immunotherapy in Children With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

— SLIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506843
• Other study ID #: F3046
• Secondary ID: CNPq
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: January 9, 2012
• Start date: October 2008
• Est. completion date: April 2011

Study information

• Verified date: August 2007
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Brazil	Asthma and Rhinitis Control Program	Itumbiara	Goias

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Uberlandia	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in Specific Antibody Levels.	Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens.	Baseline, 12 months and 18 Months