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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Staloral 300 IR, Stallergenes, France
placebo for Staloral 300 IR, Stallergenes, France
Department of Pediatrics and Allergy
Lodz, Poland
RECRUITINGClinical symptoms of asthma and allergic rhinitis and use of rescue medication
Time frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
Change of percent of regulatory lymphocytes in peripheral blood
Time frame: 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
Time frame: 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
Time frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.