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Completed

NCT Number: NCT01127035

Sublingual Immunotherapy In Alternaria-Induced Rhinitis

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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Key information

Conditions

Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rimini Hospital

Rimini, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublingual immunotherapy

Biological

Placebo

Biological

Primary outcomes

  1. change in symptom score active versus placebo

Secondary outcomes

  1. change in rescue medication intake

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 20, 2010
Registry last updated
Jun 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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