Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites

Phase 4

• Conditions: Bronchial Asthma; Allergic Rhinitis
• Interventions: Drug: sublingual house dust mites allergen extract; Drug: placebo in sublingual applicator

• Registration Number: NCT01052610
• Lead Sponsor: Medical University of Lodz

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Study Start: 2010-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active group	sublingual house dust mites allergen extract	Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract
Placebo group	placebo in sublingual applicator	Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator

Primary Outcome Measures

Name	Time	Method
Clinical symptoms of asthma and allergic rhinitis and use of rescue medication	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Secondary Outcome Measures

Name	Time	Method
Change of percent of regulatory lymphocytes in peripheral blood	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
assessment of inflammatory markers in exhaled breath condensate and FeNO	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test	Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)

Trial Locations

Locations (1)

Department of Pediatrics and Allergy; 🇵🇱 Lodz, Poland