Sublingual Immunotherapy In Alternaria-Induced Rhinitis

University of Genova

Status and phase: Completed; Phase 4

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

Treatments: Biological: placebo; Biological: sublingual immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01127035

SLITALT2004

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

27 participants in 2 patient groups, including a placebo group

SLIT

Experimental group

Description:

sublingual immunotherapy biologically standardized

Treatment:

Biological: sublingual immunotherapy

placebo

Placebo Comparator group

Description:

same preparation of SLIT without the allergen

Treatment:

Biological: placebo