Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Medical University of Lodz

Status and phase: Unknown; Phase 4

Conditions: Bronchial Asthma; Allergic Rhinitis

Treatments: Drug: sublingual house dust mites allergen extract; Drug: placebo in sublingual applicator

Study type: Interventional

Funder types: Other

Identifiers

NCT01052610

502-12-760, 503-2056-1

Details and patient eligibility

About

The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

Full description

Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study

Exclusion criteria

• active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study
• hospitalisation due to asthma exacerbation during the 3 months before the first visit
• known contraindications of SIT according to the EAACI
• previous allergen immunotherapy
• use of systemic corticosteroids
• other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or mental diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Active group

Active Comparator group

Description:

Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract

Treatment:

Drug: sublingual house dust mites allergen extract

Placebo group

Placebo Comparator group

Description:

Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator

Treatment:

Drug: placebo in sublingual applicator