Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata Clinical Trial
Official title:
STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment