Sublingual Immunotherapy In Alternaria-Induced Rhinitis
NCT ID: NCT01127035
Last Updated: 2010-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
27 participants
INTERVENTIONAL
2006-01-31
2008-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SLIT
sublingual immunotherapy biologically standardized
sublingual immunotherapy
placebo
same preparation of SLIT without the allergen
placebo
Interventions
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sublingual immunotherapy
placebo
Eligibility Criteria
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Inclusion Criteria
* Symptoms May-October
* Specific IgE to alternaria (skin test/radioallergosorbent \[RAST\] test)
* Age \>14
Exclusion Criteria
* Pregnancy-lactation
* Malignancies
* Chronic systemic steroids
* Previous immunotherapy to alternaria
14 Years
65 Years
ALL
No
Sponsors
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University of Genova
OTHER
Locations
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Rimini Hospital
Rimini, , Italy
Countries
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References
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Tabar AI, Lizaso MT, Garcia BE, Gomez B, Echechipia S, Aldunate MT, Madariaga B, Martinez A. Double-blind, placebo-controlled study of Alternaria alternata immunotherapy: clinical efficacy and safety. Pediatr Allergy Immunol. 2008 Feb;19(1):67-75. doi: 10.1111/j.1399-3038.2007.00589.x. Epub 2007 Jul 25.
Cortellini G, Spadolini I, Patella V, Fabbri E, Santucci A, Severino M, Corvetta A, Canonica GW, Passalacqua G. Sublingual immunotherapy for Alternaria-induced allergic rhinitis: a randomized placebo-controlled trial. Ann Allergy Asthma Immunol. 2010 Nov;105(5):382-6. doi: 10.1016/j.anai.2010.08.007. Epub 2010 Sep 26.
Other Identifiers
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SLITALT2004
Identifier Type: -
Identifier Source: org_study_id
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