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NCT01127035COMPLETEDanonymous

STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA

Sponsor

Source record

University of Genova

Phase

Source record

PHASE4

Modality

AI-normalized

protein therapy

Target

AI-normalized

sublingual immunotherapy, placebo

Indication / condition

AI-normalized

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

Intervention

Source record

sublingual immunotherapy, placebo

Source & freshness

Source record

NCT ID

NCT01127035

Original source

ClinicalTrials.gov

Source last updated

Jun 07, 2010

Ingested at

Jun 08, 2026

Internal sync

Jun 08, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT01127035

Title

STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA

Sponsor

University of Genova

Status

COMPLETED

Phase

PHASE4

Condition raw

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

Condition normalized

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

Modality raw

protein therapy

Modality normalized

protein therapy

Target raw

sublingual immunotherapy, placebo

Target normalized

sublingual immunotherapy, placebo

Interventions

sublingual immunotherapy, placebo

Public preview

Source record

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.

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