A Phase 4 interventional study of Staloral 300 and placebo in Asthma, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2009-05-15.
Sponsored by Medical University of Lodz · Phase 4, Interventional, and Treatment
The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of sublingual immunotherapy (SLIT) in children with asthma.
Specific immunotherapy is the only causal treatment method of atopic diseases including bronchial asthma in children. Sublingual immunotherapy seems to be the most promising alternative to traditional specific subcutaneous injection immunotherapy.
The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SLIT in children with asthma.
After two years the study will be unblinded, all the children will be given grass pollen allergen extract for a year.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 50 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Medical University of Lodz is the lead sponsor of 101 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Drug: Staloral 300
Drug: placebo
Staloral 300
placebo
clinical symptoms, reliever drugs usage, controller medication usage, lung function
Time frame: all visits
chosen markers of inflammation (specific IgE, IgG4, eosinophils)
Time frame: 1 month after baseline visit (second visit), after 5 months (fifth visit), after 18 months (ninth visit), after 30 months (thirteenth visit)
skin prick test, specific nasal provocation test with grass pollen allergen
Time frame: baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit)
bronchial hyperreactivity with methacholine
Time frame: after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit)
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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Medical University of Lodz