A Phase 4 interventional study of sublingual allergen extract and sublingual allergen extract in Allergic Rhinitis, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2011-08-22.
Sponsored by Medical University of Lodz · Phase 4, Interventional, and Treatment
The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
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 the possibility of avoiding injection this therapy allows to have better relationship with patient, and reduce the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.However efficacy and safety of sublingual immunotherapy are still important issues, especially in children.
The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 60 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Medical University of Lodz is the lead sponsor of 101 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group
Biological: sublingual allergen extract
Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group
Biological: sublingual allergen extract
Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group
Biological: placebo
Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group
Also known as: Staloral 300 IR, Stallergenes, France
Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group
Also known as: Staloral 300 IR, Stallergenes, France
Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group
Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
Visit 2 (6 months after starting the study), visit 3 (9 months after starting the study), visit 4 (12 months after starting the study), visit 5 (18 months after starting the study), visit 6 (21 months after starting the study), visit 7 (24 months after starting the study).
Time frame: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.
Change of percent of regulatory lymphocytes in the peripheral blood.
Time frame: at baseline and at the end of the second season (22 months interval)
non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.
Time frame: at the end of the first and second season of the study (12 months interval)
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Medical University of Lodz