Sublingual Immunotherapy in Children With Allergic Rhinitis

NCT ID: NCT01506843

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-04-30

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.

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

mite allergen drop

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

Group Type: ACTIVE_COMPARATOR

Mite, Mite and Bacterial or Placebo

Intervention Type: BIOLOGICAL

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

mite plus bacterial extracts

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

Group Type: ACTIVE_COMPARATOR

Mite, Mite and Bacterial or Placebo

Intervention Type: BIOLOGICAL

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Mite, Mite and Bacterial or Placebo

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Other Intervention Names

mite allergen extract; bacterial allergen extract

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Ernesto Akio Taketomi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernesto A Taketomi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

Asthma and Rhinitis Control Program

Itumbiara, Goiás, Brazil

Countries

Brazil

Other Identifiers

CNPq

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F3046

Identifier Type: -

Identifier Source: org_study_id