A Phase 4 interventional study of sublingual immunotherapy and placebo in Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata, sponsored by University of Genova. Completed at 1 site in Italy. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-06-07.
Sponsored by University of Genova · Phase 4, Interventional, and Treatment
Respiratory allergy due to Alternaria is a relevant clinical problem, and specific immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double blind, placebo controlled fashion.
Patients with rhinitis with/without intermittent asthma, and ascertained allergy to Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10 months. Symptoms and rescue medication intake are recorded on diary cards from June to October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and at the end of the study. Alternaria spore count is also performed. Primary outcome is the change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 27 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →University of Genova is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
sublingual immunotherapy biologically standardized
Biological: sublingual immunotherapy
same preparation of SLIT without the allergen
Biological: placebo
change in symptom score active versus placebo
change in rescue medication intake
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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University of Genova