Clinical trial NCT01052610: Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites
Official title: Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchial Asthma
Allergic Rhinitis
Keywords: SLIT
bronchial asthma
allergic rhinitis
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical symptoms of asthma and allergic rhinitis and use of rescue medication
timeFrame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
Secondary outcomes:
measure: Change of percent of regulatory lymphocytes in peripheral blood
timeFrame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
measure: assessment of inflammatory markers in exhaled breath condensate and FeNO
timeFrame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
measure: non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test
timeFrame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Pediatrics and Allergy
Study officials:
affiliation: Department of Pediatrics and Allergy
name: Iwona Stelmach, MD, PhD, Prof
role: STUDY_CHAIR
References: