Sublingual Immunotherapy In Alternaria-Induced Rhinitis

Phase 4

Completed

• Conditions: Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata
• Interventions: Biological: sublingual immunotherapy; Biological: placebo

• Registration Number: NCT01127035
• Lead Sponsor: University of Genova

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01
• Status Verified: 2008-01
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Last Update Submitted: 2010-06-04
• Last Update Posted: 2010-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Allergic rhinitis
• Symptoms May-October
• Specific IgE to alternaria (skin test/radioallergosorbent [RAST] test)
• Age >14

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Exclusion Criteria

• Sensitization to mites, parietaria, mugwort
• Pregnancy-lactation
• Malignancies
• Chronic systemic steroids
• Previous immunotherapy to alternaria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLIT	sublingual immunotherapy	sublingual immunotherapy biologically standardized
placebo	placebo	same preparation of SLIT without the allergen

Primary Outcome Measures

Name	Time	Method
change in symptom score active versus placebo

Secondary Outcome Measures

Name	Time	Method
change in rescue medication intake

Trial Locations

Locations (1)

Rimini Hospital; 🇮🇹 Rimini, Italy