Sublingual Immunotherapy In Alternaria-Induced Rhinitis

NCT ID: NCT01127035

Last Updated: 2010-06-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-10-31

Brief Summary

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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

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Conditions

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Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SLIT

sublingual immunotherapy biologically standardized

Group Type EXPERIMENTAL

sublingual immunotherapy

Intervention Type BIOLOGICAL

placebo

same preparation of SLIT without the allergen

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

Interventions

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sublingual immunotherapy

Intervention Type BIOLOGICAL

placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Sensitization to mites, parietaria, mugwort
* Pregnancy-lactation
* Malignancies
* Chronic systemic steroids
* Previous immunotherapy to alternaria
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Genova

OTHER

Sponsor Role lead

Locations

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Rimini Hospital

Rimini, , Italy

Site Status

Countries

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Italy

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.

Reference Type BACKGROUND
PMID: 17651380 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21055665 (View on PubMed)

Other Identifiers

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SLITALT2004

Identifier Type: -

Identifier Source: org_study_id

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